Following parliamentary committee's report to the ministry of health directing substantial changes in the Drugs and Cosmetics (Amendment) Bill, 2013, the government has decided to shelve it and replace it with a new bill incorporating major changes. It is understood that the government is planning to resubmit a fresh bill named Drugs and Cosmetics (Amendment) Bill, 2014 in parliament for discussion as early as in the current parliamentary session itself.

However, a highly placed source associated with the government informed that owing to the bureaucratic red tape and other procedural delay, chances are that the Bill may get postponed and be presented only in the next parliamentary session in March. The decision to shelve the Bill in its current form was taken after reviewing the recommendations and comments received by the stakeholders.

Interestingly, this is not the first time the bill is shelved or withdrawn, the Drugs and Cosmetics (Amendment) Bill, 2013 was first presented and introduced as Drugs and Cosmetics (Amendment) Bill, 2007, which was later withdrawn.  This is the second such incidence wherein following stiff criticism from the stakeholders the Bill has been withdrawn.

According to Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMED), this comes as a welcome move for the industry, which has been raising serious concern over some existing features in the 2013 Bill. He said, “Industry is enthused by the government's pro-activeness in respecting the industry's views in this aspect. We are happy that the government is giving due precedence to the stakeholders' recommendation along with the parliamentary committee's report. We are hopeful that the new bill will be drafted after taking into consideration all our views and comments and are looking forward to working with the government in their vision.”

Interestingly, this bill, which seeks to replace the Drugs and Cosmetics Act, 1940, contains a separate chapter for regulatory provisions for medical devices and for regulating clinical trials and export of drugs and cosmetics. Noticeably, the bill contains severe penal provisions for its violations, including imprisonment of maximum 10 years and penalty of up to Rs.30 lakh.