Drug & Medical Device Litigation India 2024.

1. Regulatory Framework

1.1        Please list and describe the principal legislative and regulatory bodies that apply to and/or regulate pharmaceuticals, medical devices, supplements, over-the-counter products, and cosmetics.

In India, the legislative and regulatory bodies regulating pharmaceuticals, medical devices, etc., operate under the aegis of the Ministry of Health and Family Welfare and the Department of Pharmaceuticals, established under the Ministry of Chemicals and Fertilizers. Various bodies have been constituted to regulate various aspects of pharmaceuticals, medical devices, etc., the most predominant of which are listed hereinbelow:

• The Ministry of Health and Family Welfare (MoHFW) – is an Indian Government ministry charged with health policy in India. It is also responsible for all Government programmes relating to family planning in India. It sits at the helm of regulatory bodies and committees relating to drugs, medical devices, etc.
• The Central Drugs Standard Control Organization (CDSCO) – under the Drugs and Cosmetics Act, 1940 and Rules, 1945 (DCA), the CDSCO is responsible for the approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country, and coordination of the activities of State drug control organisations by providing expert advice with a view to bringing about uniformity under the enforcement of the DCA.  Further, the CDSCO, along with State regulators, is jointly responsible for granting licences for certain specialised categories of critical drugs, such as blood and blood products, intravenous (IV) fluids, vaccines and sera.
• The Indian Council of Medical Research (ICMR) – is the apex body in India for the formulation, coordination and promotion of biomedical research and is one of the oldest medical research bodies in the world.
• The Indian Pharmaceutical Association (IPA) –  is a national body representing over one million pharmacists and pharmaceutical scientists from industry, academia, regulatory, hospital and community pharmacy, and works to meet India’s healthcare needs.
• The Drug Technical Advisory Board (DTAB) – was constituted by the Central Government to advise both them and the State Governments on technical matters arising out of the administration of the DCA and to carry out other functions set out under the DCA.
• The Drugs Consultative Committee (DCC) – is an advisory committee that advises the Central Government, the State Governments and DTAB on any matter associated with securing uniformity throughout India in the administration of the DCA.
• Central drug testing laboratories – these laboratories can be found in Chandigarh, Chennai, Guwahati, Hyderabad, Kasauli, Kolkata and Mumbai.  They provide analytical quality control of the majority of imported and domestic drugs and cosmetics.  The laboratories at Chennai, Kolkata and Mumbai act as the Appellate Authority in disputes relating to the quality of drugs.
• The Indian Pharmacopoeia Commission (IPC) – is an autonomous institution of the MoHFW.  The IPC was created to set a standard for drugs in India and to regularly update the standard for drugs commonly required for the treatment of prevailing diseases.
• The National Pharmaceutical Pricing Authority (NPPA) – implements and enforces the provisions of the Drugs Price Control Order in accordance with the powers delegated to it.  It also: undertakes and/or sponsors relevant studies with respect to the pricing of drugs/formulations; monitors the availability of drugs, identifies shortages, if any, and takes remedial steps; collects/maintains data on production, exports and imports, market share of individual companies, profitability of companies, etc., for bulk drugs and formulations; and renders advice to the Central Government on changes/revisions in the drug policy, etc.
• The National Institute of Pharmaceutical Education and Research (NIPER) – is an autonomous body set up under the aegis of the Ministry of Chemicals and Fertilizers.  The Institute was conceived to provide leadership in pharmaceutical sciences and related areas not only within the country but also in countries in Southeast Asia, South Asia, and Africa.
• Directorate General of Health Services (DGHS) – is a repository of technical knowledge concerning Public Health, Medical Education and Health Care and renders technical advice on all medical and public health matters to the Ministry of Health and Family Welfare.  It coordinates with the Health Directorates of all States/UTs for the implementation of various National Health Programmes through its Regional Offices of Health and Family Welfare and oversees the functioning of Central Government Hospitals and their management.  It also addresses the health concerns of the people through its Subordinate Offices/Institutes spread all over the country.
• The Review Committee on Genetic Manipulation (RCGM) – is responsible for authorising the conduct of R&D, the exchange of genetically engineered cell banks for R&D, and the review of data up to pre-clinical evaluation.
• The Genetic Engineering Appraisal Committee (GEAC) – reviews applications and approves activities where the final drug product contains genetically modified organisms/living modified organisms.
• The Pharmaceuticals Export Promotion Council of India (Pharmexcil) – promotes pharmaceutical exports from India.  All the exporters of pharmaceutical products must have a valid registration-cum-membership certificate issued by Pharmexcil.
• The Central Bureau of Narcotics (CBN) – issues licences for the cultivation and manufacturing of narcotic drugs for medicinal usage.

1.2        How do regulations/legislation impact liability for injuries suffered as a result of product use, or other liability arising out of the marketing and sale of the product? Does approval of a product by the regulators provide any protection from liability?

Liabilities for injuries suffered because of product use or the marketing and sale of the product arise from two situations.  In one situation, an injury does not necessarily occur, but the liability is attached to the manufacturer or the seller if the product is defective.  In another situation, an actual injury does occur due to the use or marketing and sale of a product.

The DCA, the Consumer Protection Act, 2019 (CPA) and the Indian Penal Code, 1860 (Penal Code) prescribe penalties for manufacturers and sellers of any drug, cosmetic or medical device that contravene the manufacturing and sale requirements under the DCA or if such products are otherwise adulterated or spurious.  Penalties include imprisonment and a fine.

In cases where there has been actual injury to a user, liability arises under the CPA and the user of a defective/spurious product may seek damages against the manufacturer and seller.  In case of any bodily injury suffered by a user due to a spurious or adulterated product, the manufacturer and seller may be penalised under the Penal Code.

Even for misleading advertisements, hefty penalties may be imposed on a manufacturer/seller under CPA provisions.  Advertisements in India are regulated by the Advertising Standards Council of India (ASCI), and complaints of misleading advertisements made to the ASCI are escalated to the Consumer Complaints Council under the CPA, which may take necessary action.

The DCA empowers the Central Government under Section 26A to prohibit the manufacture, etc., of drugs and cosmetics in the public interest and to regulate or restrict the manufacture, etc., of the drugs in the public interest under Section 26B.  This Act empowers the Central Government under Section 33 to make rules and, exercising this power, revise Cosmetics Rules 2020, which were notified on 15 December 2020.

As per the Cosmetic Rules, 2020, no inspection is required before granting the cosmetic licence, but the State Licensing Authority (SLA) may verify the documents and fees submitted by the firm as per Rule 23 of the Cosmetic Rules, 2020.  Rule 26 mentions “Conditions of license or loan licence for manufacture of cosmetics”, which mandate the manufacturer to inform the Licensing Authority within 30 days, in writing, in the event of a change in labelling or composition or testing, or specification or in documentation of any of the cosmetic pertaining to the licence along with an undertaking that the products comply with standards laid down by the Bureau of Indian Standards as referred in the Ninth Schedule.

Draft Drugs and Cosmetics (Amendment) Rules, 2018, which were notified in Official Gazette G.S.R. 999(E) on 5 October 2018, are now operative and were published in the Official Gazette on 28 December 2023.  These rules further amend the Drugs Rules, 1945 and have revised Schedule M with the introduction of a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), and guidelines for equipment validation, which reflects an emphasis on ensuring drug product quality, as well as the responsibility of manufacturers to guarantee products’ fitness for intended use and compliance with licensing requirements to align with patient safety concerns.

Although there is no law that provides that approval of a product by the regulators gives immunity or protection from liability, the law does require that manufacturers inform the Licensing Authority if a drug is recalled from the market and also report product defects, deterioration or faulty production, according to the recently notified 28 December 2023 Rules stated above.