From clarity on medicines that combine two or more drugs, to initiatives that boost bulk drug manufacturing or pharmaceutical clusters -- a slew of Government directives are expected shortly, top government officials said.

And this, even as the Government targets the forthcoming Budget session of Parliament to introduce the Drugs and Cosmetics (Amendment) Bill, 2015.

Clinical trials

Come February, clinical trial approval time will be down to a month, from the earlier four to six months. “We have constituted large panels of subject experts,” and at any time at least 20 panels would be involved with evaluating and processing, said K L Sharma, Joint Secretary with the Health Ministry. Nothing will be pending with the Drug Controller General of India for over a month, he told pharma industry representatives at an event organized by the Indian Drug Manufacturers’ Association.

DCGI GN Singh clarified that submissions for clinical trials will be evaluated by the different panels, and once it comes to his office for final approvals, it would be processed in a month. The Government was formalising a stringent regulatory framework to govern this segment, because it was required, he added.

Drugs & Cosmetics Bill

Sharma further urged pharma industry representatives to submit their suggestions at the earliest on the Drugs and Cosmetics (D&C) Bill, since the Government too had its targets – to introduce the Bill in the Budget session and hopefully have it passed in the same period.

The proposed D&C Act also covers clinical trials and medical devices. But the last word on clinical trials has not been said, as the issue is still in court, he said.

Food safety

On food safety, he said, about 12,000 product standards will be cleared in a couple of months, and there will be an outer time limit for product approvals, he said, adding that queries cannot be raised in perpetuity.

Giving more details on changes expected on the clinical trial front, he said, it would involve a more simplified process. It has been reduced by 37 per cent and the aim is to reduce forms etc by 50 per cent, he said. A clearer picture on this would emerge by end March, he indicated.

Combination drugs

On the re-evaluation of fixed-dose combination (FDC) drugs, he asked industry representatives why some of them had got local approvals on some FDCs, when they knew the Centre was to approve it. He said the Government would be “ruthless” in implementing laws governing the segment.

The FDC committee would submit its report later this month, and while there could be some discussion on doubtful combination drugs, he added, the irrational ones would have to go. And irrationality has nothing to do with the cut off date for approvals, he said, indicating that it would have to do more with the science than technicalities. About 6,500 applications had been received for re-assessment,

On replacing plastic bottles with glass for medicines, he said, no decision had been taken yet and the Government wouldn’t do anything in haste.

IDPL for clusters

VK Subburaj, Secretary with the Department of Pharmaceuticals, pointed out the dependence Indian drugmakers were having on one country for raw material and added that the committee looking into this would submit its report this week to the Prime Minister’s Office. He indicated that there would be much support to make bulk drugs in India. Similar initiatives are on the radar for medical devices as well.

But in an effort to boost manufacturing , he said, to help small and medium enterprises (SME) they would look at utilising land “idling” at the Indian Drugs and Pharmaceuticals Ltd or IDPL’s Hyderabad, Rishikesh and Chennai sites to develop pharma-parks. IDPL is a pharmaceutical public sector company.

The coming financial year, starting April would see financial support schemes for SMEs, besides the formalization of a more scientific approach to developing pharma clusters, he added.

jyothi.datta@thehindu.co.in

Published on January 12, 2015