The Union health ministry is all set to commence drafting of Drugs and Cosmetics (Amendment) Bill to amend the Drugs and Cosmetics Act, 1940 for upgradation and introduction of provision for newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trials after the Budget.

This would be in step with the central government’s ‘Make in India’ initiative. The move was welcomed by Organisation of Pharmaceutical Producers of India (OPPI).

According to a senior health ministry official, the work on draft of Drugs and Cosmetics (Amendment) Bill will begin after the Union Budget which is scheduled for February 1. The Bill proposed to cover new areas of biological, stem cells and regenerative medicines, clinical trials as well as compliance to regulatory issues. We are coming up with separate legislations for regulating medical devices and drugs and cosmetics. A set of draft rules for medical devices was prepared by the ministry and released last year. The Medical Device Regulations will be issued within a week, he added.

The Bill aimed at strengthening regulatory mechanism to ensure delivery of safe and quality medicines and facilitating ease of doing business in India will be finalized with consultation of all stakeholders including pharma industries, patient groups etc. Meanwhile we are revising regulations pertaining to new drugs, clinical trials, cosmetics to meet our current challenges and regulatory compliance requirement by amending the existing Drugs and Cosmetics Rules, the official added.

In June 2016 the government had withdrawn the Drugs and Cosmetics (Amendment) Bill, 2013 as it believed that would not be appropriate to make further amendments in the existing Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial or investigation cannot be effectively regulated under the present law. The Bill had been introduced in the Rajya Sabha. A Standing Committee of Parliament had made a number of recommendations for changing the provisions of the Bill.

Meanwhile, the OPPI has welcomed the decision of the government to revisit the Drugs & Cosmetics Act & the Rules. Amendment of the 1940 legislation would undoubtedly ensure delivery of safe and quality medicines and at the same time facilitate ease of doing business in India.

Given the dynamic nature of law as well as continuous advancement in science, importance of updated, effective, and streamlined drug regulations becomes paramount. OPPI believes that amendment in the existing regulations would certainly help remove ambiguities, augment research and innovation in India which, in turn, will enable bringing in new medicines to save and improve the lives of Indian patients.

“OPPI is appreciative of the fact that the Committees constituted by the Government to look into various aspects of law such as new drugs, clinical trials, manufacture etc. are engaging with stakeholders in the evolutionary process. OPPI looks forward to a continued engagement with the government in its endeavour to establish a transparent, process-driven and standardised regulatory structure," said Kanchana TK, Director General, OPPI.