Govt To Amend DnC Rules To Prohibit Promotion Of Schedule G Drugs
New Delhi, 26 Dec 2018: In a bid to prevent pharmaceutical companies from making misleading claims about the curative abilities of drugs specified under Schedule G, the Central government is getting ready to amend the Drugs and Cosmetics (D&C) Rules of 1945 to incorporate a new clause in conditions for obtaining a manufacturing licence.
Advertisement and promotion of drugs specified in Schedule H, H1 and X are currently prohibited as per Rule 74 and 78 of the D&C Rules without the previous sanction of the government. However, for Schedule G medications such as hormonal drugs, antihistamines and medicated skin creams, there is no provision for prohibition of advertisements which is leading to self-medication. Once the amendment takes effect, firms cannot advertise Schedule G drugs without prior nod of the government. The plan, approved by the Drug Technical Advisory Board, is learnt to be prompted by a representation from the Food and Drugs Administration of Goa, which has cited misleading advertisements.
As per the current rules, Schedule G medicines have to carry on their label a cautionary note that it should be taken only under medical supervision. The caution should be conspicuously printed and it is necessary to make proper bill of sale.
According to industry sources, certain Schedule G medications are widely advertised by manufacturers in the absence of a clear rule on promotion.
The government has also constituted a sub-committee to examine whether Schedule G can be avoided altogether and shift the listed drugs to Schedule H. The seven-member sub-committee headed by Dr. AK Gadpayle, Additional Director General of Health Services at the health ministry, is asked to look into the issue and submit a report to the DTAB.
The new panel is also mandated to conduct periodic review of marketed drugs to decide on their inclusion or deletion in Schedule H. It may be noted that a standing committee set up earlier for the purpose “could not convene due to unavoidable circumstances”, according to the minutes of the DTAB meeting.
Industry experts have welcomed the plan as a step in the right direction. “Many of these advertisements are misleading the public and can lead to adverse drug reactions, so they should be checked. Personally, I think Schedule G drugs can be part of Schedule H, which will automatically stop such promotions. Moreover, there is a dire need of defining and regulating over-the-counter (OTC) medications,” Dr BR Jagashetty, former adviser to the Central Drugs Standard Control Organisation and former Karnataka drugs controller told Pharmabiz.
The D&C Act has no provision to regulate the distribution or promotion of OTC drugs. The products that don’t fall under prescription drugs category are generally considered as OTC drugs.Pharmabiz