Drugs, Medical Devices & Cosmetics Bill to be Tabled in Parliament

The scope of the Bill includes regulation of clinical trials for new drugs, clinical evaluation of investigational medical devices, and the clinical performance evaluation of new in vitro diagnostic medical devices.

The Drugs, Medical Devices and Cosmetics Bill, which seeks to replace the 83-year-old Drugs and Cosmetics Act, has been set to be tabled in the ongoing session of the Parliament. The new Bill seeks to replace the pre-Independence Drugs and Cosmetics Act, 1940, and several other Rules.

This Bill aims to regulate the import, manufacture, distribution, and sale of drugs, medical devices, and cosmetics while ensuring their quality, safety, efficacy, and performance.

The scope of the Bill includes the regulation of clinical trials for new drugs, clinical evaluation of investigational medical devices, and the clinical performance review of new in vitro diagnostic medical devices.

Further, it applies to a wide range of products, including Ayurveda, Unani, Siddha, Sowa-Rigpa, and homoeopathy drugs, medical devices, and cosmetics.

Although the draft had been under development for an extended period, it was officially posted on the ministry's website last year. Following its publication, the draft received a substantial response from the public, garnering approximately 9,000 comments and suggestions.

Stakeholders Expressed Concerns

However, stakeholders from the medical devices industry, patient groups, and healthcare providers expressed their concerns on the Centre's reported move to table the New Drugs, Cosmetics & Medical Device Bill, 2023 in Parliament without adequately addressing them.

According to them, the key issues such as regulatory complexities, the potential impact on innovation, and the need for a conducive business environment have yet to be adequately assured by redressal in the bill.

AiMED Forum Coordinator Rajiv Nath, while expressing his disappointment, said, “The need of the hour is a progressive modern separate law for addressing patient safety concerns. NITI Aayog had drafted an excellent Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 but in vain and we keep going in circles. Who gains from putting Indian manufacturers at a disadvantage over imports and by Drug pharmacists weighed biased regulatory controls? Even the impactful recent progressive legislations in countries like Canada, UK, EU, Brazil, Malaysia, Singapore and Saudi Arabia were not studied. Who blocked that progressive visionary Bill?” asked Nath.

Nath emphasised that including penalties and punitive measures shared with drugs, only revives the Inspector Raj, posing a risk as India strives for self-reliance under the 'Make in India' initiative.

Stakeholders' statement highlights concerns about treating medical devices akin to drugs for regulation, citing the undue compliance burden on manufacturers and the oversight of crucial safety and effectiveness aspects. Moreover, they express disappointment over the disregard of Parliament Committee recommendations and health-related concerns.

In August this year, a report by think tank GTRI revealed that the Indian medical device market can grow from $12 billion to $50 billion, lowering its reliance on imports to 35% and increasing exports from $3.4 billion to $18 billion. It further reported that owing to India's growing health sector, the industry's development potential could outpace that of the smartphone market.