In what is expected to usher in a seminal transformation in the pharma sector of the country, the Centre is likely to table the Drugs, Medical Devices and Cosmetics Bill, 2023 in Parliament in the upcoming session.
Once enacted, this law will replace the pre-independence and now obsolete Drugs and Cosmetics Act, 1940, which is lacking in many aspects in the present global scenario.
Gujarat’s pharma industry, which contributes around 30% nationally, believes that once passed, the law will be at par with international legislations and bring the best global regulatory practices to support the Indian pharma and medical device industry.
It will bring issues like medical devices and clinical trials among others into legal ambit.
Consultations have been held with Gujarat’s drug controllers and industry associations and according to industry sources, the proposes constituting the Drugs Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB).
There will be specific provisions for recall of drugs, cosmetics and medical device by the manufacturer and will benefit patients. While import of drugs, cosmetics, medical devices, and clinical trials of new drugs and clinical investigation of new medical devices will be regulated by the central government, states will govern sale and distribution.
Once enacted, the legislation will promote ease of doing business, decriminalise minor offences and promote upgradation of Indian pharma industry to global quality standards. It will also support Atmanirbhar Bharat in API (active pharma ingredients) and medical devices industries by promoting growth of these segments.
An association office-bearer said, “Once the bill is passed, the new regulation of drugs, cosmetics and medical devices will ensure their quality, safety and efficacy with proper ecosystem for encouraging the research, development and innovation of new products. Regulation of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) will promote quality of medical products at supply chain level also.”
The bill has provisions for emergency use approval and accelerated approval of new drugs and investigational medical devices besides specific provisions for compensation in condition of injury or death of participant, along with the medical management of such participants in trials. It lists provisions for risk-based classification of medical devices and has norms related to powers to prohibit, restrict and regulation of sale of drugs, cosmetics and medical devices online.