The Health Ministry may notify Drugs & Cosmetics Act amendment on spurious drugs in a phased manner beginning with the guidelines and shelving the harsh provisions of making manufacturing and marketing of counterfeit drugs a non-bailable offence. This will be a big relief to the industry, especially the small manufacturers, who have been apprehensive of its misuse.

In the first phase, the ministry will issue notification by spelling out the guidelines to implement the newly amended legislation by the drug inspectors and other enforcement authorities. The penalty provisions will be notified only later, once adequate safeguard mechanism was put in place, it is learnt.

The sub-committee formed by the DCC on the subject has made its recommendations in this regard and submitted it to the DTAB after a couple of meetings with the industry members and top officials like the DCGI. The recommendations were already accepted by the recent meeting of the DTAB and the minutes of the same had been sent for approval. Once the minutes were approved, it will be forwarded to the Ministry for notification, which is likely to come by the first week of May, sources said.

The committee was set up to recommend the measures to combat the spurious drugs menace and suggest ways and means for coordination between the States for effective implementation of the provisions of the recently amended legislation which enhanced the penalty for offenders and made it a cognizable offence.

The guidelines and rules, now expected to be notified, would give right direction to the drug inspectors to enforce the law and check the counterfeit manufacturing and trade. But the contentious provision of making it a cognizable offence would be implemented at a later stage with adequate safeguards to curb the misuse of the law as feared by the industry.

"There is a clause to implement the act in a phased manner. We are going in for a staggered implementation to avoid any hardships to the genuine players while making sure that those involved in the crime are spotted and checked," DCGI Dr Surinder Singh confirmed to Pharmabiz on this issue.

Recently talking to the industry people at a conference, joint secretary in the health ministry Debasish Panda also assured that the apprehensions of the industry had been taken into consideration and enough safeguards would be put in place to make it transparent and ensure that no abuse of the law would take place.