The Union Ministry of Health has published a draft The Medicines, Medical Devices and Cosmetics Bill, 2022Once implemented, the current pre-independence Drugs and Cosmetics Act 1940 (hereafter referred to as the D&C Act) will be repealed.
The D&C Act currently governs the manufacture, distribution and importation as well as the efficacy, safety and compliance of drugs and cosmetics sold in India with state quality standards. With the changing times, technology plays a major role in drug discovery, development, clinical trials as well as the rise of online pharmacy portals, updating current laws is the need of the hour. The bill seeks to address these growing concerns. The main provisions of the bill are as follows:
- New definitions: For clarity, efficient operation and effective enforcement, the bill adds a number of new definitions or provisions to Chapter I, including medical devices, drugs, new drugs, over-the-counter drugs , cosmetics, adulterated cosmetics, bioequivalence study, bioavailability study, clinical trial, clinical investigation, control authority, manufacturing among others.
- Medical equipement must be treated separately and distinct from medicines: currently all medical devices are covered as ‘medicines’ and regulated under the Medicines and Cosmetics Act and Medical Devices Rules 2020. The Bill has now intends to repeal the current laws and proposes a new definition of medical devices outside the scope of “drugs”. In addition, Chapter II of the draft bill recommends the establishment of a Medical Devices Technical Advisory Board (MDTAB), separate from the Drugs Technical Advisory Board (DTAB), comprising specialists from various associations to recommend the central government in technical matters.
- As part of the new bill, provisions to name or construct medical device testing facilities for the purpose of evaluating and testing medical devices for regulators and businesses have also been included.
- Constitution of the Drugs, Medical Devices and Cosmetics Advisory Committee: Advise the central government, state governments, the Technical Advisory Council on Drugs and the Technical Advisory Council on Medical Devices on any matter and ensure uniformity across the country in the administration of this Act and the rules under it ensue. The Controller of Drugs General, India (DCGI) will be the chairman of the said committee.
- Chapter III deals with the standards established for the importation of drugs and cosmetics. Chapter IV deals with the manufacture, sale and distribution of drugs and cosmetics and clinical trials of drugs. While Chapter VI deals with the standardization of import, manufacture, sale and distribution and clinical investigation of medical devices.
- Chapter V of the bill has a separate chapter for Ayurvedic, Unani, and Siddha drugs and cosmetics that are currently covered by the D&C Act. Furthermore, this chapter intends to regulate Sowa Rigpa and homeopathy for the first time, including standardizing its import, manufacture, sale, distribution and clinical trials of these products.
- The Central Medicines Regulatory Authority for Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy medicines and cosmetics, appointed by the central government, regulates the manufacture and sale of these medicines and cosmetics. The central regulatory authority shall also develop such infrastructure, at the state level, as prescribed by the central government to effectively enforce the provisions of this Act for the quality assurance of such drugs and cosmetics.
- E-pharmacy: For the first time, legislation to regulate the highly unregulated and ever-growing space of online pharmacies is expected to be introduced. The draft law now aims to control e-pharmacies and it is therefore clearly specified that no person may himself or by any other person on his behalf sell, store or display or offer for sale or distribute , any medicine by the online mode (e-pharmacy) except under and in accordance with a license or authorization issued in the manner that may be prescribed. However, the draft law does not yet mention the procedure and guidelines for licensing online pharmacies which can be established after consultation with the central government.
New provisions concerning clinical trials introduced:
- Currently, the Medicines and Clinical Trials Rules 2019 are the only regulation in this regard. Now, a separate chapter has been included in the bill for clinical trials and investigations. The bill prohibits clinical trials or clinical investigations of drugs and medical devices without authorization from the central licensing authority.
- The central government was authorized to create measures allowing the Central Licensing Authority to waive the need to carry out clinical trials for the production or importation of new drugs or experimental new drugs into the country for the benefit of public health or during the drug emergency period.
- The bill makes investigators responsible for the medical treatment of any injuries resulting from the trial.
- The bill provides for compensation to participants or their legal heirs for injury or death sustained during clinical trials and investigations of drugs and medical devices.
- There is a new provision for imprisonment and a fine of twice the amount of compensation if compensation is not paid. This is seen as a welcome change as a monetary compensation of a few lakhs was no deterrent for big companies pursuing lawsuits to date, while imprisonment could be one.
It is relevant to note here that the bill provides a mechanism to regulate the online sale or distribution of medical devices, which will be a welcome move for the industry. However, how such sale or distribution is approached, including addressing issues related to the sale of counterfeit, spurious and mislabeled products, as well as intermediary liability issues inherent in the online pharmacy industry, we’ll see. The expectation is to see the final law that comes into force and the impact and effectiveness with which it can empower authorities to enforce drug, cosmetic and medical device regulations in the country.