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Pharma companies marketing medicines made by third parties in India shall be liable for any quality issues as per CDSCO

A proposal was approved by The Drugs Technical Advisory Board (DTAB) recently to amend the Drugs & Cosmetics Act to make pharmaceutical marketing firms accountable for any violations of the regulations which means that companies marketing medicines in India will soon be as liable as the manufacturers for any violations of drug regulations that could lead to spurious or substandard medicines.

The proposal would allow checking quality issues in medicines consumed by patients which in turn will help the country’s drug regulator to penalize firms marketing medicines in cases where the medicines are found to have violated the regulations. Punishment includes 3-5 years imprisonment for medicines found not of standard quality by regulators or life imprisonment in cases where the medicines are found spurious.

Approval by DTAB would enable the health ministry to amend the regulations and in turn it will make the regulations applicable to companies listed as marketers on the labels and packaging of these drugs as previously in the absence of proper legislation if a violation happens to the quality of the product then only action is taken against the manufacturer. The proposal would lead to marketing companies taking more precautions ensuring facilities and manufacturing processes as per GMP.