Third party pharma marketers soon are liable for the quality lapses flagged by CDSCO

CDSCO stands for The Central Drugs Standard Control Organization and it is the national regulatory body for Indian pharmaceuticals and medical devices. Third party Pharma manufacturing is very common in India and now the companies marketing third party pharma products, soon be liable for quality lapses flagged by CDSCO.

At present, the manufacturer sole responsible for the quality lapses but soon, the companies marketing medicines will also be liable for the quality lapses as the manufacturers. Quality of medicines lapses in India and this step will be helpful to check lapses in quality of medicines consumed by patients in the country.

A proposal has been approved by The Drugs Technical Advisory Board (DTAB) to amend the Drugs & Cosmetics Act to make pharmaceutical marketing firms liable for any contraventions of the regulations.

With this, drug regulator will get the authority to penalize the companies marketing low-standard medicines and violating the regulations. 3-5 years of imprisonment can happen if the medicines flagged by regulators are not of standard quality or life imprisonment in cases where they are found spurious.

After the DTAB approval, the health ministry gets the authority to amend the regulations, making them applicable to companies listed as marketers on the labels and packaging of these drugs. In many cases, large pharma companies assigned their product manufacturing duties and get their medicines manufactured by smaller companies and presently, If something (a violation) happens (to the quality of the product), only the manufacturer is the sole responsible. But now with this amendment, a legal action will be taken against both (the manufacturer and marketing company).

The quality of medicines will be improved with this as it will encourage the marketing companies to directly monitor their quality (before selling to patients). Manufacturing and marketing companies would definitely take precautions to ensure facilities are as per GMP (Good Manufacturing Practices) standards and that manufacturing processes are followed as required.

But according to some industry experts, this proposal acts unfairly to the marketing companies as they are not in a position to vouch for the manufacturer.

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