The health ministry has proposed changes in regulations to hold marketing companies accountable for drug product quality. The move will impact both domestic and multi national pharmaceutical companies which also outsource production to third-party units. This is chiefly done due to capacity constraints at plants or to use facilities for export purposes.
Under the Drugs and Cosmetics Rules, the manufacturer of drug is held responsible for product quality and is liable for action in case of defects. Currently there is no liability on the marketing company for drug quality under these rules. The ministry plans to amend the rules to make marketing companies responsible for quality and has invited industry comments on proposed rule change.
"Legal accountability of marketing companies is absolutely essential for protecting patients interests especially given a situation where large pharma companies are making healthy profits from the sale of medicines that they themselves are not involved in manufacturing," said Malini Aisola of All India Drugs Action Network.
A senior government official said that rules were being changed as larger pharmaceutical companies were passing on the buck to smaller contract manufacturers when products are found to be sub-standard.
At present a drug manufacturer is responsible for product quality and labelling while marketing companies require a licence to sell and stock goods. The changes in rules would make companies more accountable and increased scrutiny could also improve product quality, feel experts.
"We believe that quality should be embedded in every stage of the medicine-making process and across the delivery chain — from the R&D laboratory to the pharmacy where the patient buys the drugs. We, therefore welcome the proposal mooted by the health ministry to make marketing companies responsible for product quality and ensure availability of medicines with assured standards & safety," said Kanchana TK, director general of Organisation of Pharmaceutical Producers of India..
"We are examining the proposed rules but we welcome all measures which focus on quality and patient safety," added Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance.