Quality issues: Regulator looks to tighten marketing & sale of drugs
India's drug regulator plans new rules for medicine marketers. Companies will need a license to sell and distribute drugs. This aims to improve drug quality and safety. The move will impact domestic and multinational firms. It is expected to help ...
Amid persistent concerns around quality of medicines available in the country, the drug regulator is looking to tighten oversight of drug marketers and bar sale and distribution of medicines without a licence from the authority.
The regulator may amend the Drugs and Cosmetics Rules to bar sale and marketing of any drug without first obtaining a licence, according to a government document.
At present, there is no specific provision in the rules to monitor drug marketers' activities and to hold them accountable for the quality, safety and efficacy of products they sell.
The rules define marketers and make them responsible for the quality of the drugs as well as other regulatory compliances. "However, presently there is no detailed provision for monitoring the functions of such marketers to ensure quality, safety and efficacy of products marketed," the document said.
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"It is therefore proposed that rules may be amended incorporating various provisions for issuance of license including various conditions. This will enable the licensing authority to monitor such marketers and to have a comprehensive database of such marketers for various regulatory actions," it said.
ET has seen a copy of the document.
"In many cases, the marketer's details (address and constitution details) are also not readily available for communication for various regulatory purposes," it said. "Provisions need to be included in the rules, requiring that no marketer shall market any drug without license obtained from the licensing authority."
The move is set to impact many domestic and multinational companies. There are many pharmaceutical companies that market medicines made by third parties.
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Industry executives said this will help check spurious drugs while some said it will hurt both small and big companies.
India's top drug advisory body had in 2018 approved the proposal to amend the Drugs and Cosmetics Act to make pharmaceutical marketing firms liable for any contraventions for regulations.
