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Big Pharmaceutical Companies Face Action For Marketing Unapproved Drugs

Big Pharmaceutical Companies Face Action For Marketing Unapproved Drugs


NEW DELHI, 17 JUNE 2018: The Centre is trying to plug a legal loophole that allows major drug manufacturers to sell and market products, such as emergency contraceptives and anti-obesity and fertility formulations, which haven't undergone clinical trials to establish their risk and efficacy.

 

The amendments to the Drugs and Cosmetics Act will be intended to ensure that companies are responsible for quality of the product if their name is on the label after leading pharmaceutical firms were found selling unapproved new medicines.

 

Some of these drugs are not approved for human use anywhere in the world.

 

The Union health ministry and Drugs Controller General of India (DCGI) raided as many as 15 facilities in the last three months and have issued show cause notices to companies, including Wockhardt, Intas, Macleods and others for violations.

 

The DCGI probe revealed most of these drugs were made by small contract manufacturers in Uttarakhand, Himachal Pradesh, Sikkim and Daman. The more reputed and recognisable firms were marketing the drugs under their label across the country.

 

"We have filed an FIR and investigations are going on. We have issued show cause notices to all the companies involved in manufacturing as well as marketing such drugs. Once the investigation is over, we will initiate prosecution against those found guilty," an official told TOI.

 

Email queries sent to the companies concerned on Friday did not elicit any response till Saturday evening.

 

The official said regulatory inspectors during raids found active pharmaceutical ingredients (API) or raw material used in making medicines which were imported from China as food items.

 

If convicted under the drugs and cosmetics Act, defaulters may face imprisonment for three to five years along with a Rs 1 lakh fine.

 

But big pharma companies, which market these drugs, look to escape the penalty as under the present law, only the manufacturer is responsible for quality of the product. Hence, smaller players that are contracted for manufacturing the drugs are the ones liable for quality under the existing law.

 

Health secretary Preeti Sudan has written to chief secretaries of these states to ensure manufacturing licences for such drugs are granted after due diligence of documents and proper inspection of facilities.

 

Companies often avoid seeking regulatory approvals for new drugs to save investments on clinical trials and other procedures, and secondly to gain fast access to market.

 

Clinical trials and approvals usually take around a year. Several companies queue up to seek approvals and an an advantage of even a month can be significant to establish brand value.

 

The drug law mandates companies to seek approval from the Centre before launching any new drug for a period of four years. Findings of clinical trials play a major role in grant or rejection of approvals.  The Times Of India