Marketing of unapproved drugs: Amendment in Act aimed to hold Pharma Giants Responsible

New Delhi: Pharmaceutical companies, including the big ones are now under the radar of the central government which is planning to crack down on all those firms which are marketing unapproved drugs in the country.

TOI reports that the centre is trying to plug a legal loophole that allows big drug makers to sell and market products like emergency contraceptives and anti-obesity and fertility formulations without clinical trials and checking their risk and efficacy. This comes as the government is moving to amend the Drugs and Cosmetics Act to this effect

The amendments to the Drugs and Cosmetics Act will be intended to ensure that companies are responsible for the 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.

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

Read Also: Selling Unapproved FDC drugs: Wockhardt, two others under CDSCO scanner

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 recognizable firms were marketing the drugs under their label across the country.

An Official told TOI “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.”

During the raid, it was found that the active pharmaceutical ingredients (API) or raw material used in making medicines which were imported from China as food items.

Defaulters may have to face imprisonment for three to five years along with Rs 1 lakh fine if they were convicted under the Drugs and Cosmetics Act.

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

TOI has reported that Health secretary Preeti Sudan has written to chief secretaries of these states in order to ensure the manufacturing licenses for such drugs are granted after due diligence of documents and proper inspection of facilities.

The approval of the drug and Clinical trials usually takes around a year and several companies queue up to seek approvals and an advantage of even a month can be significant to establish their brand value.

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