There are many pharmaceutical marketing companies in India, who do not have their own manufacturing set up and do only marketing as part of business activity. Now sooner, these companies are liable as the manufacturers for any violations of drug regulations that could lead to spurious or substandard medicines.
The move is expected to check lapses in quality of medicines consumed by patients in the country, according to persons aware of the development.
The Drugs Technical Advisory Board (DTAB) last week approved a proposal to amend the Drugs & Cosmetics Act to make pharmaceutical marketing firms liable for any contraventions of the regulations, a senior government official told ET on condition of anonymity.
This would allow the country’s drug regulator to penalise firms marketing medicines in cases where the medicines are found to have violated the regulations, the official said. This includes punishment like 3-5 years imprisonment for medicines flagged by regulators as not of standard quality or life imprisonment in cases where they are found spurious, the official added. DTAB’s approval would allow the health ministry to amend the regulations, making them applicable to companies listed as marketers marketers on the labels and packaging of these drugs, according to the official.
“A company which is getting (drugs) manufactured by a third party has to be responsible for the quality of the product. Today, the law puts all the responsibility only on the manufacturer,” said DG Shah, secretary general of the Indian Pharmaceutical Alliance, a lobby group for large domestic pharma companies in the country.