Pharma cos marketing medicines made by third parties to soon be liable for quality lapses flagged by CDSCO
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 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 on the labels and packaging of these drugs, according to the official.
“Many a times, big pharmaceutical companies get their medicines manufactured by smaller companies. Today, if something (a violation) happens (to the quality of the product), only the manufacturer can be held responsible,” said the official. “Now, legal action will be taken against both (the manufacturer and marketing company).”
The amendments are expected to make these companies liable for substandard and spurious samples of medicines marketed in the country as well as violations of any labelling norms, the official said. “This will improve quality of medicines sold here because it will encourage the marketing companies to directly monitor their quality (before selling to patients),” the official added.
"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.
“If, from the outset, the legislation is clear and the responsibilities are defined, then marketing companies would take precautions to ensure facilities are as per GMP (Good Manufacturing Practices) standards and that manufacturing processes are followed as required,” he said.
At the same time, some industry executives feel this development would be detrimental to pharmaceutical firms marketing products manufactured by third parties as it would make them liable for errors that they have not committed.“It would be unfair for marketing companies. They are not in a position to vouch for the manufacturer,” said an executive requesting anonymity
Comments
Post a Comment