4 Oct 2022 7:34 AM GMT
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")...
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:
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.
Authors: Jinni Sinha, Partner and Sakshi Arora, Senior Associate, at Link Legal. Views are personal.