Pharma Firms Under Scanner For Selling Drugs Without Safety Trials

New Delhi, 20 March 2018: Worries over combination drugs flooding the Indian market without being tested for efficacy or safety emerged again, with many domestic drug makers coming under the scanner after raids by the central drug licensing authority last week.

An inquiry has been initiated by the Central Drugs Standard Control Organization (CDSCO) against Wockhardt Ltd, Ambic Aayurchem Ltd, Mascot Health Series Pvt. Ltd and Medley Pharmaceuticals Ltd, after the raids allegedly revealed that the companies were selling fixed dose combination (FDC) drugs without conducting safety trials.

The Drug Controller General of India (DCGI) will send show-cause notices to these companies on Tuesday for selling combination drugs to treat diabetes and fungal infection without mandatory prior approval, asking them to reply within 10 days, failing which legal action will be initiated against them under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, two people aware of the matter said, requesting anonymity.

According to the rules, new drugs cannot be sold unless they are approved by DCGI.

The DCGI office on Monday wrote to the Union health ministry asking it to instruct state licensing authorities (SLAs) to cancel product permissions of these companies.

“The health secretary will soon write to the Chief secretary of Uttarakhand issuing directions under section 33P of the Drugs and Cosmetics Act to instruct their drugs licensing authorities to refrain from granting such licences. The secretary will also write to the principal secretaries of all the states to examine if any new drug approvals have been granted by the state licensing authorities without prior approval from the CDSCO,” said one of the two people cited above.

DCGI is also contemplating setting up an “intelligence cell” that will monitor the availability and movement of products.

According to CDSCO’s clinical trials rules, if the product is approved elsewhere and not in India, phase III clinical trials and bioequivalence studies are required to establish its safety and efficacy on the Indian population.

“Permission from the office of the DCGI is required in respect of FDCs falling under definition of ‘New Drugs’ before these are licensed by SLAs for manufacture for sale in the country. However, SLAs were granting licences without due approval from DCGI,” said a senior health ministry official.

As reported first by Mint on Friday, the companies had come under the scanner of CDSCO for allegedly selling drugs without conducting safety trials, thereby risking the lives of patients.

With reference to the news item that appeared in Mint, Wockhardt told BSE that it is “marketing the product (Itraconazole 100 mg and Terbinafine 250 mg tablets) which is manufactured by Mascot Health Series Pvt. Ltd.(‘Mascot’). Mascot has informed the Company that they have valid FDA licence from October 2015. Kindly take the same on your record.”

During raids, authorities seized 10,000 tablets of an antifungal combination of itraconazole 100mg and terbinafine 250mg made in Haridwar by Mascot and sold by Wockhardt.

Narendra Kukreja, managing director of Mascot, said the issue has been blown out of proportion. “For all these products necessary approval from state authorities were taken. We have followed the rules,” he said.

Emails sent to Ambic and Medley did not elicit any response till the press time.Livemint