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The Government is set to bring in an easier approval process for Tuberculosis, Hepatitis and HIV/AIDS drugs, GN Singh, Drug Controller General of India said on Thursday.
If drugs in these categories have received regulatory approvals in other markets, the Government will fast-track their clearance here to speed-up local access, Singh told Business Line.
This is part of several measures being implemented by the Government to simplify the processes around medicines, even as the Government continues to keep an eye on medicine quality, Singh told a pharma industry conclave earlier in the day. In fact, by March this year, the plan is to have about 40 product safety and development officers in the districts for surveillance, among other things. The plan is to have 650 officers in one year, he said.
Singh was participating in a quality forum organized by the Indian Pharmaceutical Alliance (IPA) that also saw the participation of multiple foreign drug regulatory authorities from the United States, United Kingdom etc.
Echoing similar thoughts on changes this year, KL Sharma, Joint Secretary with the Health Department said this year would see many regulatory changes similar to what is being seen with medical devices. Other changes underway include segments like cosmetics, good manufacturing practices etc, as part of the revamping of the Drugs and Cosmetics Act.
On the issue of spurious drugs, he said, over 47,000 drug samples had been picked up from across the country in 2015, from retail, airports, sea ports etc. Of the total samples lifted, the percentage of non-standard quality drugs was pegged at 3.16 percent and spurious drugs at 0.0245 percent, he said.
A departmental release on the subject said, ”Overall, out of the 47,012 samples tested, 13 samples were found to be Spurious and 1,850 samples were found to be ‘Not of Standard Quality’ (NSQ).”
Giving the rationale behind such a conclave, IPA’s DG Shah said, the idea was to get CEOs (Chief Executive Officers) of companies to take ownership of quality. The process had begun in April 2015, when the industry was getting adverse reports from the US regulatory authority, he said. In fact, India has the highest number of manufacturing plants (570-plus) outside the US, approved by the US regulator. But about one-third of these sites have never been visited by the regulator and “we intend to get to them, before they do,” he said, indicating that the industry was keen on addressing its regulatory issues.
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