The pharmaceutical industry and medical experts have raised concern over the Drug Controller General of India (DCGI)'s recent draft notification omitting two prescription drugs, 'chlorpheniramine maleate' and 'dextromethorphan hydrobromide' from the Schedule H of the Drugs & Cosmetics Act and placing them under over the counter (OTC) category.
In a notification dated 29th October, 2009, the health ministry has said that “In the Drugs and Cosmetics Rules, 1945, in Schedule H,- (a) The entry '107. Chlorpheniramine maleate' shall be omitted; (b) the entry '145. Dextromethorphan hydrobromide' shall be omitted”.
According to experts, once these drugs are removed from the Schedule H of the D&C Act, they automatically come under the OTC category which can be sold by the chemists without any prescription from doctors. Under the D&C Act, 1940, only hard core drugs come under Schedule H and they should be sold only by prescription of qualified doctors.
They say that as there are no guidelines for selling and purchasing of OTC drugs in India, drugs omitted from Schedule H are sold as OTC drugs by chemists without prescription. This may result in misuse and over dosage of these medicines. The problem will be compounded by the fact that since a large number of populace in India still remains illiterate and their knowledge about self-medication is limited, there is an added possibility of the misuse and over dosage of these medicines. Besides, not many chemists in the country employ qualified pharmacists who could guide the patients about the efficacy of the medicines and their side-effects, if any.
Chlorphenamine maleate is a first generation alkylamine antihistamine used in the prevention of the symptoms of allergic conditions such as rhinitis and urticaria. While, dextromethorphan hydrobromide' is indicated as anti-cough medicine which contains narcotic substances.
Meanwhile, the Indian Drugs Manufacturers Association (IDMA) has written to the DCGI voicing its concern over the issue.