The Ministry of Health and Family Welfare (MoHFW) introduced a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (Draft Bill) on July 08, 2022. The Draft Bill seeks to replace the existing law i.e., the Drugs and Cosmetics Act, 1940 (Act). The suggestions, comments and objections, if any, can be forwarded to the MoHFW within 45 days from the notice of the Draft Bill.
Some quick questions that came to our mind on the Draft Bill are discussed below.
Q. What do you see as the prime objective of the Draft Bill?
A. The Act is a pre-independence legislation which does not conform to the technological and medical advancements and simultaneous legal developments that have occurred from time to time over a period of last few years. The primary objective of the Draft Bill seems to be to accommodate these advancements and developments. As counsels for pharma and healthcare companies, we understand that the industry has felt the need to amend and consolidate the Act to eliminate the scope of conflicts that could crop up while interpreting the Act and the rules that have been introduced over the last few years specifically to regulate medical devices, clinical trials, cosmetics and the draft rules for e-pharmacies.
At the first look, one would see a definition of medical device being incorporated in the legislation, which was notified on February 11, 2020 with an intention to broaden the scope of medical devices and set the ball rolling for the registration requirement to be made applicable. Other expected definitions that can be seen include clinical trials, over-the-counter drugs, manufacturers, new drugs, bioavailability studies, investigational new drugs and imported spurious drugs. The Draft Bill proposes an overall structural change with introduction of provisions on manufacture, sale, distribution and clinical trial of drugs and on import, manufacture, sale, distribution and clinical investigation of medical devices.
In short, the entire regulatory periphery governing pharma and healthcare is at an evolving stage where many aspects need to be streamlined – yes, it does look like that the Draft Bill will be a common thread running through and bringing new subjects, streams and aspects of pharma and healthcare industry together.
Q. What is the status of the rules to the Draft Bill?
A. No new set of draft rules have been made available in relation to this Draft Bill. The Draft Bill specifies that till the government formulates new rules upon the Act being repealed, the standards and the rules specified in the nineth schedule of the Draft Bill will remain in force.
Presently, the nineth schedule of the Draft Bill specifies the list of rules made under the Act, namely, the Drugs Rules, 1945, the Medical Devices Rules, 2017, the New Drugs and Clinical Trials Rules, 2019 and the Cosmetics Rules, 2020.
It can be expected that when the Draft Bill becomes the law, the existing rules under the Act will also be amended for the reasons of compatibility with the proposed legislation.
Q. To what extent have the provisions relating to clinical trials been incorporated in the Draft Bill?
A. The clinical trials never found a mention in the Act as trials were unregulated until intervention of the Supreme Court of India pursuant to a public interest litigation filed in 2013 against the unethical nature of clinical trials in the country. A writ of mandamus was sought to direct the legislature to create and implement a better regulatory framework for the same.
Until recently before introduction of the New Drugs and Clinical Trials Rules in 2019 (CT Rules), these were regulated by Schedule Y of the Drugs Rules, 1945. In order to cut down conflict, the CT Rules provide that in case there is any discrepancy between the CT Rules and the Drugs Rules, 1945, the CT Rules will apply.
To ensure compliance with Schedule Y and the CT Rules, the MoHFW has now introduced provisions relating to clinical trials in the Draft Bill and schematised the regulatory framework around clinical trials. The Draft Bill provides for permission to conduct clinical trials and more importantly, compensation provisions are also provided for in case of injury or death related to clinical trials. Thus far there was no specific penalty prescribed for violation of any procedure in relation to conducting clinical trials. The Draft Bill now proposes to introduce penalty provisions if the clinical trials are conducted without permission, if they violate any condition of permission granted to conduct clinical trials, or in case of failure to provide compensation.
Q. What is the expected impact on e-pharmacy segment?
A. As of now, the e-pharmacy segment is not regulated. The uncertainty in the regulatory framework of e-pharmacy is not conducive for the fast-paced digital markets. The Draft E-Pharmacy Rules were put out for comments from stakeholders by the MoHFW in 2018 (E-Pharmacy Rules). The E-Pharmacy Rules were formulated with an intent to regulate the procedure for distribution or sale of drugs through e-pharmacy and the registration requirements. These are yet to be finalised.
This Draft Bill proposes to regulate online mode of sale and distribution of any drug by introducing licensing and permission requirements. Under the Draft Bill, the government has the power to make rules for the manner of regulation and restriction for online sale or distribution of any drug and medical devices.
Therefore, the provisions of the Draft Bill are reflective of the government’s intention and plans to introduce regulations governing e-pharmacy segment either simultaneously or before the Draft Bill. This can be welcomed given the fact that e-pharmacy industry is only likely to expand.
Q. What are the other aspects of the Draft Bill?
A. Few other aspects introduced in the Draft Bill are discussed below, including some administrative changes that have been proposed.
- Constitution of Medical Devices Technical Advisory Board: The Draft Bill proposes for the constitution of a separate Medical Devices Technical Advisory Board to advise the government in technical matters pertaining to medical devices arising out of the administration of the Draft Bill.
- Setting up of Medical Devices Testing Centres: The Draft Bill also provides for setting up of Medical Devices Testing Centres for testing and evaluation of medical devices and carrying out other functions.
- Constitution of the Ayurveda, Siddha, Sowa-Rigpa, Unani, Homeopathy Drugs, Medical Devices and Cosmetics Consultative Committee: The Draft Bill proposes to constitute this committee for the purpose of securing uniformity throughout India in administration of ayurveda, siddha, sowa-rigpa, unani, homeopathy drugs, medical devices and cosmetics. Also, a Scientific Research Board is proposed to be introduced to support the regulatory authority on the scientific advances used for developing such drugs and to ensure their safety, efficacy and other related matters.
- Import of drugs in public interest: The Draft Bill proposes permission to import a drug if the government is satisfied that a drug is essential to meet the requirements of an emergency arising due to an epidemic or a natural calamity and if in the public interest, it is required to do so. This provision is reflective of government’s intention to align efforts towards permitting “compassionate use of a drug”, the importance of which was realised in the recent times during the pandemic.
Accessibility to the COVID-19 vaccine being of extreme concern led the Indian government to bring about an amendment to the CT Rules in June 2020. This amendment made a provision for permitting import or manufacturing of a new drug for compassionate use for the treatment of patients suffering from a life-threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, where such new drug is not approved under the CT Rules but is under phase-III of the clinical trial in India or any other country. The above amendment helped COVID-19 patients to get access to treatments involving drugs, which were not available in India then and were pending trials outside India. Most of the countries had access to the sought after anti-viral drug, namely, “Remdesivir” (vastly used to treat COVID-19 patients) under statutory provisions for compassionate use of the unauthorized drug.