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Draft amendment to Drugs Rules, 1945, seeks prior government approval for advertisements of Schedule H, H1 and X medicines across the drug supply chain to curb unauthorised promotion and misuse.
The Union Health Ministry has proposed tighter restrictions on advertisements of prescription medicines, seeking to bring drug retailers, wholesalers and distributors under rules that require prior Central Government approval.
The move aims to close a gap in existing regulations, which restrict pharmaceutical manufacturers from advertising certain prescription drugs without government approval but do not explicitly extend the same requirement to retailers and wholesalers.
The proposed amendment to the Drugs Rules, 1945, covers medicines listed under Schedules H, H1 and X, including certain antibiotics, psychotropic drugs and other prescription-only medicines that require medical supervision.
Why does this matter?
Unauthorised promotion of prescription medicines could encourage people to seek or use drugs without appropriate medical advice. This can increase the risk of inappropriate self-medication, particularly when medicines require a doctor’s supervision.
Under the proposed rules, businesses holding licences to sell, stock, exhibit, offer for sale or distribute these medicines would not be allowed to advertise them without prior approval from the Central Government.
In simple terms, the restrictions would extend beyond drug manufacturers to the wider supply chain, including retail chemists and wholesale suppliers.
The proposal does not seek to ban the sale of prescription medicines. Instead, it aims to regulate their advertising and strengthen safeguards against their unauthorised promotion.
More from BusinessThe ministry said the move aims to strengthen oversight across the pharmaceutical supply chain, curb unauthorised promotion and reduce risks linked to inappropriate self-medication. The restrictions would cover medicines requiring medical supervision, including certain antibiotics and psychotropic drugs.
What happens next?
The government has invited objections and suggestions from stakeholders and members of the public within 30 days of the draft Gazette notification being made available.
The submissions will be examined before the amendment is finalised. The proposed restrictions are not yet final rules and will take effect only after the government completes the process and brings the amendment into force.
The existing framework restricts pharmaceutical manufacturers from advertising such drugs without approval but does not explicitly extend the same requirement to retailers and wholesalers.
