Life Sciences 2022 Comparisons

The key pieces of legislation and regulation governing pharmaceuticals and medical devices are as follows.

• The Drugs and Cosmetics Act, 1940 (the "DC Act") and the Drugs and Cosmetic Rules, 1945 (the "DC Rules") regulate the manufacturing, importation, sale and distribution of pharmaceuticals in India.
• The Medical Device Rules, 2017 as amended from time to time (the "MD Rules") under the DC Act, along with the DC Rules, regulate the importation, manufacture, sale and distribution of all medical devices. Furthermore, the medical device is required to conform to the standards laid down by the Bureau of Indian Standards Act, 1985 or as may be issued by the Ministry of Health and Family Welfare (MoHFW), from time to time. Where no relevant standard for a medical device has been laid down, it is required to conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electrotechnical Commission, or any other pharmacopeial standards. If the standards have not been specified under any of the above two bodies, the device is required to conform to the validated manufacturer’s standards.
• The New Drugs and Clinical Trials Rules, 2019 as amended from time to time (the "CT Rules") under the DC Act regulate clinical trials, bio-equivalence studies, bio-availability studies and the Ethics Committee (EC) for new drugs and investigational new drugs for human use.        
• The Narcotic Drugs and Psychotropic Substances Act, 1985 (the "NDPS Act") regulates production/manufacturing/cultivating, possessing, selling, purchasing, transporting, storing and/or consuming any narcotic drug or psychotropic substance.
• The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, along with the DMR Rules, 1977 as amended from time to time, regulates the advertisement of medicinal products.
• The Uniform Code of Pharmaceuticals Marketing Practices issued by the Department of Pharmaceuticals (DoP) also provides directions on suitable promotional materials for medicinal products. 
• The Code for Self-Regulation in Advertising issued by the Advertising Standards Council of India, a non-statutory body, regulates the publishing of advertisements in India, including medicinal products.
• The Consumer Protection Act, 2019 prohibits false advertisements by misrepresentations or false allurements.
• The Medicinal and Toilet Preparations (Excise Duties) Act, 1956 provides for the levy and collection of duties of excise on medicinal products.
• The Essential Commodities Act, 1955 and the Drugs (Prices Control) Order 2013 (DPCO) thereunder regulate the price of drugs and medical devices specified in the National List of Essential Medicines (NLEM).
• The Rules for the manufacture, use, import, export and storage of hazardous micro-organisms/genetically engineered organisms or cells, 1989, issued under the Environment (Protection) Act, 1986 (the "1989 Rules"), regulate hazardous micro-organisms/genetically engineered organisms or cells.
• The Foreign Trade (Development and Regulation) Act, 1992 (the "FTDR Act") and the rules thereunder provide for the development and regulation of foreign trade.
• The Biodiversity Act, 2002 (the "BD Act") and the rules thereunder provide a mechanism for benefit sharing arising out of the use of traditional biological resources and knowledge.

In addition to the above, there are specific guidelines for various issues; for example, the conduct of clinical trials, market authorisation of biosimilars, ribosomal DNA (rDNA) research, ethics, and the privacy of healthcare-related data.

Regulatory Bodies/Committees/Authorities

The following are the key regulatory authorities in respect of drugs and medical devices.

• The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General of India (DCGI) is responsible for the implementation of the DC Act and the rules thereunder. It exercises regulatory control over the importation of drugs, the approval of new drugs and clinical trials, and meetings of the Drugs Consultative Committee and the Drugs Technical Advisory Board (DTAB). It also acts as a Central Licensing Authority (CLA) and co-ordinates the activities of state drug control organisations (SDCOs).
• SDCOs – the SDCO of a particular state regulates the manufacture, sale and distribution of drugs, medical devices and cosmetics at the state level. It monitors the quality of drugs, cosmetics and medical devices in the concerned state. It also acts as a state licensing authority (SLA).
• There are various authorities and regulatory bodies for implementing the provisions of the NDPS Act; for example:
1. the Narcotics Control Bureau (NCB) – the functions of the NCB include drug law enforcement, receipt, and monitoring of returns regarding controlled substances under the NDPS (Regulation of Controlled Substances) Order, 1993, etc;
2. the Central Bureau of Narcotics (CBN) – the functions of the CBN include licensing and supervision of the cultivation of the opium poppy, the licensing of manufacture of narcotic drugs, and control on the importation and exportation of narcotic drugs, and psychotropic substances and precursors.
3. state governments – the functions include control on sale, use, consumption and movement of narcotic drugs, usually through the state excise department; framing rules regarding permission and regulation of cultivation of any cannabis plant; and production, manufacture, possession, transport, import and export inter-state, sale, consumption or use of cannabis (excluding charas).
• The Indian Council of Medical Research (ICMR) – the ICMR is the apex body for the formulation, co-ordination, and promotion of biomedical research.
• The Department of Pharmaceuticals – the DoP regulates various issues related to pricing and the availability of medicines at affordable prices, research and development, protection of intellectual property rights, and international commitments related to the pharmaceutical sector that require integration of work with other ministries.
• The National Pharmaceutical Pricing Authority (NPPA) – the NPPA is responsible for monitoring, fixing and revising the prices of drugs and medical devices, and enforcement of the provisions of the Drugs (Prices Control) Order, 2013.
• The Review Committee on Genetic Manipulation (RCGM) – the RCGM is responsible for authorising the conduct of research and development, the exchange of genetically engineered cell banks for research and development, and the review of data up to pre-clinical evaluation.
• The Genetic Engineering Appraisal Committee (GEAC) – the GEAC reviews applications and approval of activities where the final drug product contains genetically modified organisms/living modified organisms.
• The Department of Biotechnology (DBT) – the DBT is responsible for administrating development and commercialisation in the field of modern biology and biotechnology.
• The State Biotechnology Co-ordination Committee (SBCC) – the SBCC is responsible for inspecting, investigating and taking punitive action in the case of violations of statutory provisions through the State Pollution Control Board (SPCB) or the Directorate of Health, etc.
• The District Level Biotechnology Committee (DLC) – the DLC is responsible at the district level for monitoring the safety regulations in installations engaged in the use of genetically modified organisms/hazardous micro-organisms and their applications in the environment.
• The Institutional Biosafety Committee (IBC) – the IBC is the nodal point for the implementation of the biosafety guidelines and the interactions within an institution.
• The gazetted officers authorised by the state governments to enforce drug advertising regulations.
• The Bureau of Indian Standards (BIS) – the BIS is responsible for the harmonious development of the activities of standardisation, marking, and quality certification of goods and matters connected therewith or incidental thereto.
• The Pharmaceuticals Export Promotion Council of India (Pharmexcil) – the Pharmexcil promotes pharmaceutical exports from India. All the exporters of pharmaceutical products must have a valid Registration-cum-Membership Certificate issued by Pharmexcil.
• The Directorate General of Foreign Trade is involved in the regulation and promotion of foreign trade under the FTDR Act.
• The National Biodiversity Authority and state biodiversity boards are the main regulatory bodies under the BD Act. 

Any person who is aggrieved by any order passed by the CLA or the SLA may file an appeal to the central government or the state government respectively within the stipulated period. The respective government may make necessary orders after an inquiry and after hearing the appellant.

Pharmaceuticals and medical devices are regulated according to their categories. The DC Rules provide for the classification of drugs in various schedules. Each schedule has a guideline for labelling, storing, selling, displaying and prescribing a listed drug. The schedules are as follows:

• Schedule C – biological and immunological products, antibiotics, ophthalmic preparations and all products for parenteral use;
• Schedule C(I) – drugs of biological origin, namely alkaloids, hormones, vitamins and antibiotics for oral use;
• Schedule G – drugs that can be administered only under the supervision of a registered medical practitioner;
• Schedule H – drugs that are required to be dispensed on the prescription of a registered medical practitioner;
• Schedule H1 – drugs including antibiotics, habit-forming drugs and a few anti-tuberculosis medicines;
• Schedule K – over-the-counter drugs; and
• Schedule X – psychotropic drugs that are required to be dispensed on the prescription of a Registered Medical Practitioner (RMP). A special retail licence is required for selling these drugs.

Similarly, the MD Rules provide for a risk-based classification of all medical devices.

• Medical devices, except in vitro diagnostic medical devices, are classified according to Part I of the First Schedule, as follows:
1. low risk – Class A;
2. low to moderate risk – Class B;
3. moderate to high risk – Class C; and
4. high risk – Class D.
• In vitro diagnostic medical devices are classified according to Part II of the First Schedule, as follows:
1. low risk – Class A;
2. low to moderate risk – Class B;
3. moderate to high risk – Class C; and
4. high risk – Class D.

The CDSCO, via the CLA, regulates the clinical trials of drugs and medical devices. A clinical trial is required to be conducted in accordance with the Good Clinical Practice Guidelines issued by the CDSCO.

The CT Rules regulate clinical trials, bio-equivalence studies, bio-availability studies and investigations into new drugs for human use. The DC Rules regulate clinical trials for veterinary drugs.

The MD Rules regulate the clinical investigation of medical devices and the clinical performance evaluations of new in vitro diagnostic medical devices. The EC for clinical investigations of medical devices is constituted in accordance with the DC Rules.

The National Guidelines for Gene Therapy Product Development and Clinical trials, 2019 (the "GTP Guidelines") provide guidance for conducting clinical trials in areas pertaining to gene therapy.

The National Ethical Guidelines for Biomedical and Health research involving human participants, 2019 and the National Ethical Guidelines for Biomedical Research involving Children (collectively, the "Ethical Guidelines") provide general guidance for ethically conducting clinical trials involving adults and children.

In order to obtain market authorisation for any of the following, one is required to conduct detailed clinical trials, or investigations or performance studies, as the case may be, for the following.

• New drug – a "new drug" is considered "new" for a period of four years from the date of its first approval and can be any of the following:
1. a drug that has not been used in India to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof, and has not been recognised as effective and safe by the CLA for the proposed claims; also, the limited use, if any, has been with the permission of the CLA;
2. a drug already approved by the CLA for certain claims, which is now proposed to be marketed with modified or new claims; namely, indications, dosage, dosage form (including sustained-release dosage form) and route of administration;
3. a fixed-dose combination of two or more drugs individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims; namely, indications dosage, dosage form (including sustained-release dosage form) and route of administration;
4. a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the CLA; or
5. a vaccine, rDNA-derived product, living modified organism, monoclonal antibody, cell or stem cell-derived product, gene therapeutic product or xenografts intended to be used as a drug; a modified or sustained-release form of a drug; or a novel drug delivery system of any drug approved by the CLA.
• An investigational new drug – a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.
• Investigational medical device – a device that does not have a predicate device or a device that, after being authorised for marketing, claims for a new intended use or a new population, or a new material or a major design change.
• New in vitro diagnostic medical device – any in vitro diagnostic medical device covered under the MD Rules that has not been approved for manufacture for sale or for importation by the CLA and is being tested to establish its performance for the relevant analyte or other parameter related thereto, including details of the technology and procedure required.

An online application for conducting a clinical trial can be filed in a prescribed format with all the necessary documents and information. The CLA is required to evaluate the application within the prescribed time. An application for drugs discovered, researched and manufactured in India is required to be evaluated within 30 days. If the CLA does not respond within 30 days to the application for drugs developed in India, the applicant may conclude that permission to conduct the trial has been granted.

The clinical trial can be initiated only after the approval of the trial protocol and other related documents by the EC. If the EC rejects the protocol, the details of the same should be submitted to the CLA before seeking approval of another EC for conducting the clinical trial at the same site. The CLA is informed about the approval granted by the EC within the stipulated time of the grant of such approval. The CLA may grant permission to conduct the clinical trial or reject the application for reasons to be recorded in writing. The permission to initiate a clinical trial remains valid for two years from the date of its grant.

The MD Rules discuss two types of clinical investigations: a pilot study and a pivotal study. A pilot study is an exploratory study that is used to acquire specific essential information about a medical device before beginning the pivotal clinical investigation. A pivotal study is a confirmatory study to support the safety and effectiveness evaluation of the medical device for its intended use. For an investigational medical device developed in India, the applicant is required to conduct pilot and pivotal studies in India.

Waiver of the Requirement for a Local Clinical Trial in Certain Cases of New or Investigational Drugs

The CLA, with approval from the central government, may waive the requirement for a local clinical trial for the approval of a new drug already approved in other countries in the following cases.

• The new drug is approved and marketed in countries specified under the CT Rules, and no unexpected serious adverse events have been reported, and:
1. there is no probability or evidence, on the basis of existing knowledge, of difference in the Indian population of the enzymes or gene involved in the metabolism of the new drug or any factor affecting the pharmacokinetics and pharmacodynamics, safety and efficacy of the new drug; and
2. the applicant has given an undertaking in writing to conduct a Phase IV clinical trial to establish the safety and effectiveness of such new drug as per the design approved by the CLA.
• For the importation of a new drug for which the CLA had already granted permission to conduct a global clinical trial, which is ongoing in India, and in the meantime this new drug has been approved for marketing in a country specified under the CT Rules, and:
1. there is no probability or evidence, on the basis of existing knowledge, of difference in the Indian population of the enzymes or gene involved in the metabolism of the new drug or any factor affecting the pharmacokinetics and pharmacodynamics, safety and efficacy of the new drug; and
2. the applicant has given an undertaking in writing to conduct a Phase IV clinical trial to establish the safety and effectiveness of such new drug as per the design approved by the CLA.

Furthermore, the requirements may be relaxed, abbreviated, omitted or deferred in the case of life-threatening or serious disease conditions, or rare diseases, and for drugs intended to be used in diseases of special relevance to the Indian scenario or for an unmet medical need in India, a disaster or a special defence use.

The CLA may relax the requirement of local Phase IV clinical trials where the new drug is indicated in life-threatening or serious diseases, or diseases of special relevance to the Indian health scenario, or for a condition that has an unmet need in India, for rare diseases for which drugs are not available or available at a high cost, or if it is an orphan drug.

Waiver of the Requirement of Pivotal Studies in Certain Cases of New or Investigational Medical Devices

A pivotal clinical study is not required to be conducted for investigational medical devices classified under Class A of the MD Rules. However, in exceptional cases, the CLA may, for reasons to be recorded in writing, mandate conducting a pivotal clinical study of such devices as well, depending on the nature of the medical device.

For investigational medical devices developed and studied in a country other than India, the applicant is required to submit the details of the pilot clinical investigation or relevant clinical study data generated outside India along with the application. The CLA may grant permission to repeat a pilot study or to conduct a pivotal clinical investigation only.

The clinical investigation may not be required in the case of investigation medical devices approved for at least two years in the USA, the UK, Australia, Canada or Japan, if certain conditions are met.

It is mandatory to register clinical trials prospectively in the ICMR's Clinical Trials Registry – India (ICMR-CTRI), which is a free, online platform.

Trials registered on the ICMR-CTRI are publicly available and free to search.

The CT Rules and the MD Rules require the investigator of a clinical trial to give an undertaking that they will maintain the confidentiality of the identities of all the participants and ensure the security of the clinical trial data.

The Ethical Guidelines set out the principle of ensuring the privacy and confidentiality of the participants of the clinical trials.

The Information Technology Act, 2000 as amended by the IT (Amendment) Act 2008 (the "IT Act") and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 (the "IT Rules") regulate the collection, storage and processing of personal data. The IT rules define the sensitive personal data or information (SPDI) of a person, which includes physical, physiological, mental health conditions and medical records and history. SPDI includes medical records and health data recorded by fitness trackers.

The Personal Data Protection Bill, 2019 was introduced in Lok Sabha by the Minister of Electronics and Information Technology on 11 December 2019. The Bill seeks to provide for the protection of sensitive personal data of individuals, including health data, and establishes a Data Protection Authority for the same.

Please see 1.3 Different Categories of Pharmaceuticals and Medical Devices.

All types of biologics, including biosimilars, are considered as "new drugs" under the DC Rules and the CT Rules. The applicant is required to conduct the following studies in respect of all types of biologics:

• pre-clinical studies;
• clinical studies; and
• post-market surveillance.

In addition, comparative data of the pre-clinical studies and clinical studies of biosimilars and reference biologics are required to be submitted for a biosimilar.

Additionally, the following regulations and guidelines are also specifically relevant for the approval of biologics:

• the 1989 Rules;
• the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016, which lay down the regulatory pathway for a similar biologic;
• the Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017, which provide guidance on handling hazardous biological material, recombinant nucleic acid molecules and cells, organisms, and viruses containing such molecules;
• the GTP Guidelines, which aim to guide and enable the stakeholders to comprehend and comply with the regulatory requirements for research and development of gene therapy products in India, and provide basic guidance for research involving human participants, including clinical trials, pertaining to the broad area of gene therapy;
• the Guidance Document for Industry: Submission of Stability Data and Related Documents for Review and Expert Opinion for Granting Post-approval Changes in Shelf Life of Recombinant Biotherapeutic Products and Therapeutic Monoclonal Antibodies, published by the National Institute of Biologicals 2016, which provides recommendations to holders of marketing authorisations for recombinant technology-based products who intend to make post-approval changes in the shelf life of such product in accordance with CDSCO guidance Document No – PAC/1108 Version – 1.1; and
• the Guidelines and Handbook for Institutional Biosafety Committee (IBSC).

In addition to the CDSCO, the approval of biologics is overseen by the RCGM, IBSC and GEAC.

An original licence or a renewed licence for the manufacture for sale or distribution of drugs, unless suspended or cancelled, is valid for five years from the date on which it is granted or renewed. If the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of an additional fee, the licence continues to be in force until orders are passed on the application.

An importation licence for a drug, unless suspended or cancelled, remains valid for three years from the date of its issue. If an application for a fresh licence is made three months before the expiry of the existing licence, the current licence is deemed to continue in force until orders are passed on the application.

The licence for manufacture, distribution, sale, importation and exportation of the medical devices granted under the MD Rules remains valid unless suspended, cancelled or surrendered. The licensee is required to pay a prescribed fee every five years to prevent the cancellation of the licence.

If the licensee fails to comply with any of the stipulated conditions prescribed under the regulations, the CLA may suspend or cancel the licence by an order in writing, stating the reasons, after giving an opportunity to show cause why such an order should not be passed.

On 11 February 2020, the MoHFW introduced a new definition of a medical device, bringing all devices under the purview of the MD Rules. On the same day, the MoHFW issued another notification requiring the registration of such newly notified medical devices on the online portal of the CDSCO according to the timeline specified therein.

On 9 February 2022, the MoHFW, in consultation with the DTAB, issued draft Medical Devices (Amendment) Rules, 2022. The draft rules stipulate that the registration certificate will be made mandatory for selling, stocking and distributing a medical device, including in vitro diagnostic medical devices. The draft rules also specify the conditions for obtaining the registration certificate, which the seller has to follow; the validity of the certificate; and the suspension or cancellation clauses for the registration certificate.

On 16 March 2022, the DoP issued a draft Uniform Code for Medical Devices Marketing Practices. The draft is proposed to be a voluntary code for the marketing of medical devices specifically. The draft provides standards for the promotion, marketing and sale of medical devices, prohibiting the distribution of gifts or benefits to healthcare professionals.

An application for market authorisation of a drug or a medical device may be filed online. For a new drug or an investigational new drug/medical device, or a new in vitro diagnostic medical device, the application must be accompanied by detailed clinical trial data. For other types of drugs, the application must be accompanied by bio-equivalence and bio-availability studies.

On 31 December 2021, the MoHFW issued the Medical Devices (Amendment) Rules, 2021, which requires that every medical device approved for manufacture for sale or distribution, or importation, shall bear a unique device identification in the manner as may be specified in such order. The rule shall come into effect on a date notified by the central government.

The DC Act and the DC Rules provide for limited access to drugs or medical devices, the importation of which is otherwise not allowed.

Small quantities of a new drug or investigational medical device may be imported for the treatment of patients suffering from life-threatening diseases, or diseases causing serious permanent disability, or a disease requiring therapies for unmet medical needs, by a medical officer of a government hospital or an autonomous medical institution providing tertiary care, duly certified by the medical superintendent of the government hospital, or head of the autonomous medical institution, subject to specific conditions.

Small quantities of a drug or a medical device, the importation of which is otherwise prohibited, may be imported for personal use subject to specific conditions. Furthermore, the importation of small quantities of a drug or a medical device donated to a charitable hospital for the treatment of patients free of cost may be allowed by the CLA.

On 5 June 2020, the central government, in consultation with the DTAB, issued draft New Drugs and Clinical Trials (Amendment) Rules, 2020 for compassionate use of any new unapproved drug for the treatment of patients by hospitals and medical institutions. However, there has not been any further development in this regard.

The holder of the market authorisation for a new drug, an investigational new drug, or an investigational medical device is under an obligation to conduct post-market surveillance or Phase IV clinical trials. The holder is required to submit a Periodic Safety Update Report as prescribed.

The DC Rules and the MD Rules mandate maintenance of records pertaining to sales, manufacture, batches, master formula, packing and processing, distribution, investigation, testing, and remedial action taken for drugs and medical devices.

The DC Rules and the MD Rules include provisions for product recall (drugs or medical devices) by the manufacturer, importer or authorised agent, as the case may be. The CDSCO has issued detailed guidelines on the Recall and Rapid Alert System for Drugs for both voluntary and statutory recall.

Third parties cannot access any information regarding pending applications for marketing authorisations for drugs and medical devices.

Adulterated, misbranded, spurious or illegally distributed drugs and medical devices are regulated under the DC Act, the DC Rules and the MD Rules, as the case may be. The manufacture for sale or distribution, selling, stocking, exhibiting or offering for sale or distribution of such drugs and medical devices is a penal offence punishable with imprisonment and/or a fine of a varying degree based on the seriousness of the offence.

The Customs Act, 1960 (the "Customs Act"), along with the Intellectual Property Rights (Imported Goods) and the Enforcement Amendment Rules, 2018 (the "IPREA Rules"), prohibits the importation of goods that infringe on intellectual property (except patents). The Customs Act empowers the customs authority to confiscate goods subject to the conditions and procedures specified under the IPREA Rules. The owner of the IP right (IPR) is required to record their IPR at the Indian Customs IPR Recordation Portal. The owner also has to sign a bond with the customs authority undertaking to pay the costs of retention/destruction of the infringing goods and to indemnify the customs office.

Furthermore, Customs can, on its own initiative, suspend the clearance of the imported goods if there is prima facie evidence or reasonable grounds to believe that the goods are infringing IPRs. In such a scenario, the rights-holder or its agent will have to comply with the requirements of the recordal within five days, else the goods may be released.

The manufacturing plants of drugs and medical devices are subjected to authorisation. The CDSCO is the main regulatory body for granting the authorisation. The manufacture of any drug, or Class A and Class B medical device, is subject to the grant of a licence by the SLA. The manufacturing of Class C and Class D medical devices is subject to the grant of a licence by the CLA.

The DC Rules lay down the requirement of factory premises, plant and equipment for manufacturing, depending on the type of drug. These rules lay down the requirement for the location, building condition (as per the Factories Act, 1948 (63 of 1948)), water treatment system, the disposal of sewage and effluents (as per the Environment Pollution Control Board), and biomedical waste (as per the Biomedical Waste (Management and Handling) Rules, 1996).

The MD Rules lay down requirements for the manufacturing of medical devices for sale and distribution. These rules also stipulate a Quality Management System that a manufacturer is required to use. The MD Rules lay down requirements for the safety and performance of medical devices.

The licence remains valid if a licence retention fee is paid, before expiry, every five years from the date of its issue unless it is suspended or cancelled by the licensing authority.

The manufacturer of the new medical devices is required to obtain a registration number under the MD Rules for the manufacturing of medical devices.

Establishments engaged in the wholesale of drugs and medical devices are subject to authorisation by the SLA.

An application for obtaining a wholesale licence to sell, stock, exhibit or offer for sale or distribute a drug or a medical device may be filed online. The licence is issued based on the category of the drug or medical device in question.

A licence issued remains valid if the licensee deposits a licence retention fee, before expiry, every five years from the date of its issue unless it is suspended or cancelled by the licensing authority.

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The DC Act and the DC Rules primarily regulate the importation and exportation of drugs in India along with other regulations. The importation and exportation of medical devices are regulated by the MD Rules along with the DC Act. The CLA grants the licence for importation or exportation subject to other relevant regulation(s).

There are no specific requirements or qualifications required for a person to act as an importer of record.

The importation of drugs and medical devices in India is subject to prior authorisations from the CLA. Limited access to unauthorised drugs and medical devices is allowed in specific circumstances with specific conditions; see 3.5 Access to Pharmaceutical and Medical Devices without Marketing Authorisations.

The importer of the new medical device is required to obtain a registration number under the MD rules for importing medical devices (see 3.3 Period of Validity for Marketing Authorisation for Pharmaceutical or Medical Devices).

The importation of drugs and medical devices into India is primarily regulated by the CDSCO under the DC Act, the DC Rules and the MD Rules, as the case may be, along with other regulations. The DC Act and the MD Rules also stipulate labelling requirements for imported drugs and medical devices. For example, the importation of the following is prohibited:

• any patented or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it, together with the quantities thereof; and
• any drug that – by means of any statement, design or device accompanying it or by any other means – purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed.

Furthermore, the central government has powers to prohibit the importation of drugs and medical devices in the name of public interest.

India is a party to several regional and bilateral trade agreements, such as those with the United Arab Emirates, and various African and Asian countries. These trade agreements facilitate trade of various goods, including pharmaceuticals and medical devices.

The DPCO controls the price of drugs and medical devices listed in the NLEM, which is updated from time to time based on the recommendation of the MoHFW. The NPPA is the regulatory body that regulates and monitors the price of drugs and medical devices in India.

The DPCO provides a formula for calculating the ceiling price and the maximum retail price (MRP) of the listed drugs and medical devices. In extraordinary circumstances, the government may fix the ceiling price or the retail price of any drug or medical device in the public interest. Also, if the ceiling price or the retail price of the drug is already fixed and notified, the government may allow an increase or decrease in the same.

The DPCO sets out conditions that the manufacturers, dealers and distributors are required to follow for listed drugs and medical devices. Furthermore, the DPCO stipulates that the government monitors the MRP of all drugs and medical devices, including non-listed drugs and medical devices, and ensures that no manufacturer increases the MRP of a drug by more than 10% during the preceding 12 months.

According to the NPPA Policy, 2012, the key principles for the regulation of a drug price are:

• the essentiality of drugs;
• the control of formulation prices only; and
• market-based pricing.

The DPCO provides that, at least initially, the source of market-based data will be the data available with IMS Health, the pharmaceuticals market data specialising company, and if the government deems it necessary, it may validate such data by appropriate survey or evaluation.

The government funds and operates several healthcare/insurance schemes for reimbursement of the costs of pharmaceuticals and medical devices for people of weaker economic sections and government employees; for example, Ayushman Bharat and the Central Government Health Scheme. 

The government has created an institutional arrangement called the Health Technology Assessment in India (HTAIn) under the Department of Health Research. HTAIn is responsible for collating and, where needed, generating evidence related to the clinical effectiveness, cost-effectiveness and safety of medicines, devices and health programmes using the health technology assessment approach.

The Indian National Cost database under the arrangement aims to provide a one-stop shop for cost information for healthcare decision-making in India.

The prescription of drugs by a physician or a medical practitioner is regulated by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (amended 2016) (the "IMC Regulations"), which stipulate that:

• a physician shall write their name and designation in full along with registration particulars in their prescription letterhead;
• every physician should prescribe drugs with generic names legibly and preferably in capital letters, and they shall ensure a rational prescription and use of drugs;
• the attending physician may prescribe medicine at any time for the patient, whereas the consultant may prescribe only in the case of an emergency or as an expert when called for; and
• the prescription should also make clear if the physician dispensed any medicine.

Furthermore, the DC Rules stipulate that the prescription must be in writing, and signed and dated.

The Pharmacy Act, 1948 prohibits a person other than a registered pharmacist from the compounding, preparing, mixing or dispensing of any medicine prescribed by a medical practitioner.

According to the new definition of a medical device under the MD Rules, any software or app used with an instrument or an article for diagnosis, prevention or monitoring of diseases/disorders may be classified as a medical device (please see 3.1 Product Classification: Pharmaceutical or Medical Devices).

Please also see 8.2 Rules for Telemedicine.

The IMC Regulations regulate telemedicine and provide guidelines for technology platforms such as mobile apps and websites enabling telemedicine. These guidelines provide information on various aspects of telemedicine, including information on technology platforms and tools available to RMPs, and how to integrate these technologies to provide healthcare. They also spell out how technology and transmission of voice, data, images and information should be used in conjunction with other clinical standards, protocols, policies and procedures for the provision of care. They also cover norms and standards for the RMP to consult patients via telemedicine.

Furthermore, they require RMPs to obtain the patient’s consent and maintain the records/documents for the period as prescribed from time to time. An RMP can provide medical attention through a mobile device.

There are no special rules for the promotion and/or advertising of medicines and medical devices through online portals, company web pages and social networks. See 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices.

Electronic prescriptions are regulated and allowed in India.

According to the IMC Regulations, 2020, RMPs providing teleconsultation can send an e-prescription or a digital copy of a signed prescription to the patient via email or any messaging platform. It entails the same professional accountability as a traditional in-person consultation. There are certain limitations on prescribing medicines on consultation via telemedicine depending upon the type of consultation and mode of consultation. The regulations also provide categories of medicines that can be prescribed via telemedicine that are notified from time to time. Pharmacies can dispense prescription drugs only on the production of a valid prescription.

Under the IT Act, where the law requires a document to be signed, it would be deemed to be legal only if digitally signed.

There are currently no specific rules that govern online sales of drugs and medical devices.

Specific rules for the regulation of e-pharmacies are expected to be issued in the near future.

On 26 March 2020, due to COVID-19, the MoHFW allowed the retail sale of drugs by a licensee to the doorstep of consumers against prescriptions received by email, to meet the requirements arising because of the pandemic.

The Electronic Health Record Standards for India, 2016, issued by the MoHFW, provides for standardisation and homogeneity, and interoperability in the capture, storage, transmission and use of healthcare information across various health IT systems.

The IT Act, the IT Rules and the Information Technology (Intermediaries Guidelines) Rules, 2011 govern the protection of data. On 24 August 2017, a nine-judge bench of the Supreme Court ruled that the right to privacy is a fundamental right for Indian citizens under Article 21 of the Indian Constitution.

The IT Rules provide guidelines that need to be followed by a body corporate while collecting, storing and transferring information. Obtaining consent from the person providing the information is one of the most important requirements of the IT Rules. The person must be aware that the information is being collected, its purpose and intended recipients, as well as the names and addresses of the agencies collecting and retaining the information. The body corporate or any person on its behalf holding SPDI shall not retain that information for longer than is required. The disclosure of SPDI by the body corporate to any third party requires prior consent from the provider of such information.

In August 2020, the National Digital Health Mission (NDHM) was launched by the central government. The objective of the NDHM is to digitise India’s healthcare ecosystem. It also aims to provide a health ID to all medical practitioners, clinical establishments and patients.

In December 2020, the central government approved the Health Data Management Policy (HDMP) of the NDHM. Among other things, the HDMP provides the framework for the creation of health IDs. Under the HDMP, the patient has complete ownership over the health data. It also provides a framework for the utilisation of this data.

On 11 February 2022, the National Health Authority, under the scheme of the Ayushman Bharat Digital Mission (ABDM), announced integration with Aarogya Setu. Under the ABDM, a user can generate a 14-digit unique Ayushman Bharat Health Account (ABHA) number. The ABHA number can be used to link their existing and new medical records – including doctor prescriptions, lab reports and hospital records – and share these records with registered health professionals and health service providers, and access other digital health services while maintaining a common pool of medical history.

Patents are regulated in India under the Patents Act, 1990 and the Patents Rules, 2003 (the "Patents Rules"). The most common issue encountered by patent applicants is patentability of the subject matter for which a patent is sought. Apart from being novel, inventive and useful, the subject matter must not fall within a list of inventions specifically excluded from patentability. Specific exclusions with respect to pharmaceuticals and medical devices are:

• an invention that could be contrary to public order or morality;
• any living thing or non-living substance occurring in nature;
• mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance;
• the mere discovery of any new property or new use for a known substance;
• a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;
• mere arrangement or re-arrangement or duplication of known devices, each functioning independently of one another in a known way;
• any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products;
• plants and animals in whole or any part thereof; and
• traditional knowledge.

Second and subsequent medical uses of a known product are not patentable in India. Use, per se, is not patentable in India.

There are no mechanisms for patent term extension in India.

The following acts when performed with the consent of the patentee constitute an infringement of a patent:

• making, using, offering for sale, selling or importing for those purposes a patented product in India; and
• using a patented process, and using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India.

The Patents Act provides for the following defences to patent infringement:

• use of a patented invention on foreign vessels or aircraft temporarily or accidentally within the territory of India;
• making, constructing, using, selling or importing a patented invention solely for use reasonably related to the development and submission of information required under any law that regulates the manufacture, construction, use, sale or importation of any product in India or any other country;
• importation of patented products by any person who is duly authorised under law to produce and sell or distribute the product;
• importation or manufacture of a patented product or a product made by a patented process by or on behalf of the government for its own use;
• use or manufacture of a patented product or a product made by a patent process or use of a patent process merely for experimentation or research, or for imparting instructions to pupils; and
• importation of the patented medicine or patented drug by the government for distribution in any dispensary, hospital or other medical institution maintained by, or on behalf of, the government or any other dispensary, hospital or other medical institution that the central government, having regard to public service, specifies by notification in the Official Gazette.

Furthermore, in any suit for infringement of a patent, every ground on which it may be revoked is available as a ground for defence.

Compulsory Licences

The Patents Act provides for a compulsory licence (CL) in certain circumstances.

• At any time after the expiry of three years from the date of grant of the patent, any person interested makes an application to the Indian Patent Office for a grant of a compulsory licence on any of the following grounds:
1. that the reasonable requirements of the public with respect to the patent invention had not been satisfied;
2. that the patented invention is not available to the public at a reasonably affordable price; or
3. that the patented invention is not used in the territory of India.
• If the central government is satisfied, in a national emergency or in circumstances of extreme urgency, or in the case of public non-commercial use, that it is necessary that a CL should be granted, it may make a declaration to that effect, by notification.
• If it is required to manufacture and export the patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector to address public health problems, provided the CL has been granted by such country or such country has, by notification or otherwise, allowed the importation of the patented drug from India.

A proceeding for patent infringement can be brought by a patentee or a holder of an exclusive licence.

Furthermore, the holder of a CL is entitled to call upon the patentee to bring such proceedings. If the patentee refuses or neglects to do so within two months after being called upon, they may institute proceedings in their own name, making the patentee a defendant.

The court may grant a relief that may include an injunction and, on the request of the plaintiff, damages or an account of profits. The court may also order that the goods that are found to be infringing, and materials and implements used in the creation of the infringing goods, shall be seized, forfeited or destroyed, as the court deems fit under the circumstances of the case, without payment of any compensation.

The invalidity of the suit patent is an available defence in the proceeding of infringement and can be invoked by filing a counterclaim by the defendant in a suit for infringement.

The generic entrant may institute a suit for a declaration that their use of a product or process would not infringe a patent if it is shown that:

• the person applied in writing to the patentee or exclusive licensee for a written acknowledgment and furnished them with full particulars in writing of the process or article in question; and
• the patentee or licensee has refused or neglected to give such an acknowledgment.

The generic entrant may also initiate opposition or revocation proceedings challenging the validity of a patent. There is also an option of obtaining a compulsory licence under specific circumstances.

There is no patent linkage in India and clearing the way is not a requirement for generic market entry.

In recent patent infringement cases, the Indian courts have introduced the concept of "clearing the way". If a party intends to use a patented product or method, they must exercise due diligence. If they fail to "clear the way", then in a court proceeding the balance of convenience may shift in favour of the plaintiff and may enable the grant of an interim injunction against the said party.

India has no specific legislation or procedures for dealing with the counterfeiting of drug and medical devices; see 3.9 Border Measures to Tackle Counterfeit Pharmaceutical and Medical Devices.

The Trademarks Act, 1999 (the "TM Act") prohibits the registration of names of chemical elements or international non-proprietary names as trade marks in India. There are no restrictions under the TM Act on the importation and distribution of non-counterfeit, genuine pharmaceutical or medical device products from other markets, regions or countries.

Although trade dress is not specifically mentioned under the TM Act, the definition of a trade mark under the TM Act includes the "shape of goods, their packaging, and combination of colours". The aesthetics of any article or product of manufacture are protected and registered in India under the Designs Act, 2000 and the Designs Rules, 2001.

There are no provisions for data exclusivity in India. Under the DC Rules, a “new drug” continues to be considered as a new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. An applicant for a new drug is required to conduct extensive testing and clinical trials for obtaining market authorisation. Therefore, an application for manufacturing generic versions of a new drug during the four-year period is required to contain clinical trial data.

The central government, the CDSCO and other bodies issued various notices and guidelines to expedite the approval of COVID-19 drugs, diagnostic kits and vaccines. Some of them are listed below.

• A special notification regarding the conduct of clinical trials to make available suitable vaccines was issued by the central government.
• The CDSCO released an office memorandum dated 26 May 2020 providing for an expedited approval process for COVID-19 vaccines. As per the memorandum:
1. pre-clinical trial data generated abroad may be considered as part of an application to conduct clinical trials; and
2. clinical trial data generated outside India may be used to provide an abridged pathway for a COVID-19 vaccine.
• Provisions were made for high-priority processing of applications for R&D, repurposing, importation, manufacturing, marketing and evaluation of drugs or vaccines and diagnostic kits for COVID-19.
• Draft Regulatory Guidelines for Development of Vaccines with Special Consideration for COVID-19 Vaccine were issued by the CDSCO. The guidelines are in the nature of recommendations and do not replace any statutory requirements. The guidelines focus on safety, immunogenicity and efficacy parameters for developing COVID-19 vaccines.
• Guidelines for validation and batch testing of diagnostic kits were issued by the ICMR-DCGI.
• Provisions were made for the relaxation of the data requirement and requirements for the importation licence.
• Emergency approvals for vaccines, Covidshield and Covaxin were granted subject to terms and conditions.
• Restricted emergency use and manufacture approvals were granted to Remdesivir and Favipiravir tablets.
• A Liberalised Pricing and Accelerated National COVID-19 Vaccination Strategy was issued by the MoHFW on 21 May 2021, which aims at liberalised vaccine pricing and scaling up of vaccine coverage.
• Revised Guidelines for implementation of National COVID Vaccination Program were issued by the MoHFW on 21 June 2021.
• Restricted emergency use and manufacturing approval were granted to Tocilizumab and an antibody cocktail (Casirivimab and Imdevimab).
• Restricted emergency use approval was granted to Molnupiravir for the treatment of adult patients with COVID-19 who have high risk of progression of the disease.
• Emergency use authorisation (EUA) was granted to Sputnik-V, the Moderna Vaccine, the Janssen Vaccine, Corbevax, and Covovax.
• EUA was granted to Covaxin for administration to children in the age group of 12–18 years.
• EUA was granted to ZyCoV-D for administration in adults and children 12 years and above.
• A guidance notification was issued by the CDSCO in May 2021 for the importation of foreign COVID-19 vaccines by a private entity or government-sector entity.
• In April 2021, the CDSCO issued detailed guidelines and relaxed the conditions for the entry of foreign-made COVID-19 vaccines approved by the US Food and Drug Administration, the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency, the Japanese Pharmaceuticals and Medical Devices Agency or the WHO emergency use listing into India.
• In June 2021, the NPPA capped the trade margin of oxygen concentrators, pulse oximeters, blood pressure monitoring machines, nebulisers, digital thermometers and glucometers at 70%.
• Guidelines were issued by the MoHFW on 3 January 2022 for COVID-19 vaccination of children between 15 and 18 years and precautionary doses to healthcare workers, front-line workers and members of the population who are 60 or over with comorbidities.

The following special measures were issued in relation to ongoing clinical trials:

• a notice regarding the conduct of clinical trials during the COVID-19 outbreak was issued by the CDSCO in March 2020;
• the registrations of BA/BE (bioavailability/bioavailability) study centres were extended;
• a clinical trial protocol for convalescent plasma was issued; and
• a notice was issued by the CDSCO on 25 February 2021, regarding the launch of software for online submission of all Serious Adverse Events reports through the SUGAM portal.

Please see 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices.

The DC Act contains provisions that allow the central government to regulate, restrict, manufacture, etc a drug in the public interest by way of notification in the Official Gazette.

Please refer to 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices, 11.2 Special Measures Relating to Clinical Trials, 11.4 Flexibility in Manufacturing Certification as a Result of COVID-19 and 11.5 Import/Export Restrictions or Flexibilities as a Result of COVID-19 for details.

The following simplifications and flexibility were introduced in relation to obtaining required certifications due to COVID-19:

• manufacturers of industrial oxygen were allowed to manufacture oxygen for medical use subject to conditions;
• the processing of applications to manufacture hand sanitisers was completed in three working days;
• hand sanitisers were exempted from the requirement of a sale licence;
• the validity of the WHO's Good Manufacturing Practices provisions and the Certificate of Pharmaceutical Products expiring from March to August 2020 was extended by six months; and
• prior permission from the CLA for manufacturing and stocking a vaccine for COVID-19 was deferred;
• the CDSCO issued various orders in 2021 relaxing the manufacturing and import licensing requirements for specified periods for all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, positron emission tomography equipment, dialysis machines, X-ray machines and bone marrow cell separators;
• on 28 September 2021, the CDSCO issued the expiry of the voluntary registration period for medical devices on 30 September 2021; going forward, Class A and B medical devices will be under a compulsory registration scheme up to September 2022 and Class C and D medical devices will be under a compulsory registration scheme up to September 2023; and
• on 18 January 2022, the CDSCO issued amended Drugs (Amendment) Rules, 2022 stating that every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear a quick response code on its label at each level packaging that stores data or information readable with a software application to facilitate tracking and tracing. These amended rules shall come into force from 1 January 2023.

The following import/export restrictions or flexibilities were introduced in relation to medicines or medical devices due to COVID-19:

• export restrictions were imposed on 26 API and formulations made therefrom;
• Draft New Drugs and Clinical Trials (Amendment) Rules, 2020 were issued for compassionate use of any new unapproved drug;
• the exportation of items such as surgical or medical masks, medical coveralls, medical goggles, nitrile/nitrile butadiene rubber gloves, face shields and PPE coveralls was completely restricted or limited to a certain quota;
• the validity of registration certificates or licences for the importation of drugs that were due to expire was extended subject to conditions;
• special conditions under which permission for the importation of drugs with a residual shelf life of less than 60% was to be allowed/extended where specified;
• a set of regulations were issued to allow for certain norms to be relaxed to facilitate ease in the importation and exportation of COVID-19 vaccines through a courier;
• the submission of applications for import registration for drugs, cosmetics and medical devices with self-attested documents was allowed, subject to conditions; and
• on 18 January 2022, the CDSCO issued amended MD Rules, relaxing those for manufacturers and importers that currently do not have U13485 certification and are in the process of obtaining ISO certification.

Please see 8.5 Online Sales of Medicines and Medical Devices and 8.6 Electronic Health Records.

No such announcement has been made so far. Regarding the rules, please refer to 9.5 Defences to Patent Infringement in Relation to Pharmaceuticals and Medical Devices.

The government has no proposal to indemnify or exempt vaccine manufacturers from liability in the event of serious adverse reactions or side-effects due to vaccines.       

Please see 11.4 Flexibility in Manufacturing Certification as a Result of COVID-19.

In 2017, the central government issued Public Procurement (Preference to Make in India) [PPP-MII] Order 2017 (with subsequent revisions in 2018–20) to encourage "Make in India" and to promote the manufacturing and production of goods, services and works in India, with a view to enhancing income and employment where there is sufficient local capacity and competition.

To implement the Order, the DoP issued Guidelines in relation to the procurement of medical devices in 2018. The Guidelines were revised in 2021.

Similarly, in 2021, the DoP issued Guidelines (in supersession of the earlier Guidelines) for implementing the Order in relation to the procurement of pharmaceutical formulations.

There has been no change due to COVID-19.