Industry Odisha Bureau, Oct 10: Retailers, wholesalers and distributors could need central approval to advertise prescription drugs. Manufacturers already face this rule for Schedule H, H1 and X medicines. The health ministry now wants it applied across the supply chain.
Drug manufacturers in India already need central approval before advertising certain prescription drugs. The Union health ministry now wants the same rule for those who sell them. It has proposed curbs on advertising by licensed retailers, wholesalers and distributors. Without prior central government approval, they could not advertise the covered medicines.
Who would be covered
The proposal targets businesses licensed to sell or distribute specified prescription medicines. Retailers sell medicines directly to customers. Wholesalers and distributors move medicines through the supply chain. All three would follow the approval rule manufacturers already observe.
Which medicines
The curbs would apply to drugs under Schedules H, H1 and X. These schedules cover prescription medicines that need medical supervision. They include certain antibiotics and psychotropic drugs.
Schedule H covers medicines that require a registered medical practitioner’s prescription. Schedule H1 lists certain prescription drugs subject to additional regulatory controls. Schedule X covers specially controlled medicines, including certain psychotropic substances. The three are distinct categories with their own regulatory roles.
Building on existing rules
The ministry is not creating a new system from scratch. Manufacturers already face this advertising requirement under the current framework. The proposal simply widens its reach to other licensed players. This could bring more consistent oversight across the pharmaceutical supply chain.
The legal route
The change would come through an amendment to the Drugs Rules, 1945. The ministry proposes inserting a new sub-rule (22) under Rule 65. This provision would extend the approval requirement to licensed sellers and distributors. The amendment remains a proposal and has not been finalised.
DTAB’s role
The proposal follows recommendations from the Drugs Technical Advisory Board (DTAB). DTAB acts as a technical advisory body in this process. Its role was to recommend, not to enact the change. The health ministry then notified the proposed amendment.
What it could mean
If adopted, the rule would bring more businesses under advertising oversight. Pharmacies and distributors would need clearance before promoting covered medicines. Such drugs are not ordinary consumer goods. They are meant for use under medical supervision. Approval checks would then apply across manufacturers, sellers and distributors alike.
Ads, not sales
The distinction between advertising and selling matters here. The proposal restricts advertising without prior approval. It does not ban the lawful sale or distribution of these medicines. Nor does it announce changes to stocking, dispensing or pricing.
A wider boundary
The plan would stretch prescription drug advertising curbs beyond manufacturers. Retailers, wholesalers and distributors would join the same approval framework. For now, the amendment remains a proposal. Its final shape and timing are yet to be decided.
