India Regulatory Diary: Marketers Co-Accountable For Lapses In Manufacturing Quality

New rules in India specify that a marketer of a drug will share the onus for quality and compliance along with the manufacturer. Enhanced punishment for misleading advertisements for a range of illnesses is also proposed, while calls for a statute to regulate pharma's marketing practices grow louder.

Regulation
New Regulations Fix Responsibility For Marketers Of Drugs • Source: Shutterstock

February 2020 has seen a flurry of regulatory activity in India, with the ministry of health and family welfare setting out norms that expand responsibility for the quality of drugs and compliance issues beyond manufacturers.

Changes have also been proposed to the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, with new prison terms and fines awaiting those who violate the provisions

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