With the rising need to accommodate the new requirements and adaptation of modern technology in the pharmaceutical sector, the draft of the ‘Drugs, Medical Devices and Cosmetics Bill, 2022’ (the “Bill”) has been released by the Ministry of Health and Family Welfare (MoHFW) on July 8, 2022, which seeks to replace the existing archaic law under the Drugs and Cosmetics Act of 1940 (“Act”) and the Drugs and Cosmetic Rules 1945 (“Rules”).
The process of review of the Act gained momentum in the last few years, and in the year 2021, the Drug Controller General of India constituted a committee to frame the Bill, on which the MoHFW has sought consultation and feedback from the public and stakeholders, within a period of 45 days from the date of issue of notice (i.e. from July 8, 2022). While the Rules have been amended a few times in the past, it is laudable that the Bill has been introduced to give a fillip to the existing law, by providing for a broader coverage of an improved and a comprehensive regulatory framework for medical devices, clinical trials and e-pharmacies, apart from medicines and cosmetics. It is yet another attempt to enforce the proposed provisions added to the existing law, to ensure synchronisation with international standards as needed, and have an improved regulatory process in place.
The Act regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India, with the primary objective to ensure that the drugs and cosmetics sold and made available to the public are safe and efficacious. The Act and the Rules have been amended over a period of time in view of the vicissitudes in the pharmaceutical industry. In furtherance to the same, the Bill has been introduced as a step forward to include the aspects that remain presently uncovered and to deal with the need to make the law more stringent, considering the rapidly evolving technology in the upstream industry of pharmaceuticals. Observing the surge in the availability of drugs on the online platform with the convenience offered thereby, especially during the Covid-19 pandemic, e-pharmacies are acquiring a major stake in the pharmaceutical retail value chain in the country. Due to such proliferation, the need to regulate e-pharmacies and have a systematic crackdown against illegally dealing with and selling of counterfeit and spurious drugs by medical stores and drugs companies is increasing with each passing day. It is hoped that enforcing the new regulations as proposed in the Bill prove to be a constructive way forward for better regulation and addressing the bottlenecks in the current framework.
The key highlights of the Bill are as follows:
- The Bill proposes to expand the definitions under the Act, by adding certain new definitions inter alia for clinical trials, over-the-counter drugs, manufacturers, new drugs, bioavailability studies, investigational new drugs and imported spurious drugs, amongst others. Also, the definition of medical devices has been inserted separately, which, under the Act, is included in the definition of ‘Drugs’.
- For regulating e-pharmacies, provisions have been introduced in the Bill that aim to govern the online sale of medicines, which the existing framework lacks dealing with and is thus prone to be misused with the increased market of online pharmacies offering drugs and virtual consultations, if not regulated. While in the year 2018 there was an attempt made to amend the Rules in order to regulate e-pharmacies, and draft rules in regard thereto were introduced and circulated, however, the same were not notified as they were considered to be deficient in dealing with the complexities associated with the retail by online pharmacies, and hence remained unenforced. To regulate this, the Bill inter alia categorically restricts ‘stocking or exhibiting or offering for sale, or distributing, any drug by online mode except under and in accordance with a licence or permission issued in such manner as may be prescribed thereunder’, thereby making the requirement of obtaining a license or permission mandatory for undertaking such activity.
- Provisions have been introduced for penalty in the form of fine and imprisonment in case of any morbidity or mortality related to clinical trials or investigations.
- In order to facilitate the smooth implementation of the Bill, advisory boards have been proposed to be constituted, namely the Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), to comprise of such professionals and experts belonging to departments of medical devices, science and technology, biomedical, biomaterials, electronics etc., as prescribed under the Bill, for supporting the Central and the State Governments and providing technical assistance. The Bill also mandates the setting up of the ‘Consultative Committee on Drugs, Cosmetics and Medical devices’ which would advise the Central and State Governments, the DTAB and the MDTAB on any matter concerning the administration of the Bill and the rules made thereunder.
- The Bill also provides for setting up of ‘Medical Devices Testing Centres’ for testing and evaluation of medical devices and carrying out such other functions as may be prescribed, at both, Central and State levels.
- Another crucial provision in the Bill pertaining to the power to regulate or restrict the import of drugs in public interest, if the drug is essential to meet the requirements of an emergency due to epidemic or natural calamities.
- An Ayurveda, Siddha, Sowa-Rigpa, Unani, Homeopathy Drugs, Medical Devices and Cosmetics Consultative Committee has been proposed to be constituted along with a Scientific Research Board for supporting on the scientific advances used for developing, innovative drugs of Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy, their safety and efficacy, devices and other such related matters. Also, provisions for import of Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs and cosmetics have been inserted in the Bill.
To conclude, while the Bill aims to provide an impetus to the existing pre-independence legislation and to meet the need for staying abreast with the ever-changing technology, it is yet to be seen how the new legislation would practically be welcomed and prove to be beneficial for accelerating the growth of the sunrise sector of the medical devices industry of India by enhancing its regulatory framework. It is hoped that the changes that the Bill proposes to bring, cater to the increasing need of addressing the inadequacy of the existing law and monitoring additional avenues of retail and other aspects in the pharmaceutical sector, which will go a long way in facilitating the ease of doing business in India.
· Jinni Sinha, Partner, Link Legal
· Sakshi Arora, Senior Associate, Link Legal