Focusing on a much expanded market penetration for the drugs and pharmaceutical products in a big way by opening up the OTC segment, the pharmaceutical industry in the country has submitted a list of 57 drugs, which are currently under prescription category, to the Drug Controller General of India (DCGI), to be allowed for deregulated marketing.

Anticipating this OTC market opportunity with responsible product promotion practices by the drug companies, a new set of guidelines for the ethical advertising of drugs is already been prepared. The new 'Code of Conduct' which is in line with the guideline of International Federation of Pharmaceutical Manufacturers Associations (IFPMA), has been prepared by a joint committee represented by the office of DCGI, OPPI and the Advertisement Standards Council of India (ASCI) would be released by the DCGI at the seminar, 'Unlocking OTC Future' organized by the OPPI on November 19, 2002.

The fresh guideline states that the 'pharmaceutical product' in the context of the Code means any pharmaceutical or biological product which is primarily intended to be used on the advice of, or under the supervision of a health care professional, and which is intended for use in the diagnosis, treatment or prevention of disease in humans, or to affect the structure or any function of the human body. The promotional activities within the scope of the Code include direct-to-consumer advertising, where this is permitted under local laws.

It recommends the pharma companies that the promotional material for pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only to legal requirements but also to high ethical standards and to be in good taste. Claims should not be stronger than scientific evidence warrants, and every effort should be made to avoid ambiguity.

According to Dr Ajit Dangi, director general, OPPI, though the industry has submitted a list of 57 drugs to be allowed OTC marketing, it has asked for only the specific dosages with maximum allowable limit. The product and brand specific label warnings will also become necessary in case the authority allows it for the nonprescription market, he said.

Earlier, in view of the industry appeal for opening up of the OTC market, the Union ministry of health had sought a proposal from the Central Drug Standard Control Organization for expanding the retail marketing of non- prescription drugs currently under Schedule G. By shifting these drugs from Schedule G, they can be sold in general and other non-medical stores in the country.

However, the proposal will lead to an extension of the current restricted licensing provision for the household medicines and the Schedule K of the Drugs & Cosmetics Act, which deals with exemption of drugs from trade license.

Schedule G drugs, which do not necessarily need a prescription to buy it from retail medical shop, are almost treated as over-the-counter drugs now. Though the rule insists the manufacturers to put the label to caution the patient as "the drug required to be taken under medical supervision," these can be purchased over the counter without a prescription. There are around 50 drugs in India placed into the category of Schedule G.

The restricted licensing provision allows the drugs known as 'household medicines' to be sold in a shop where a qualified person/pharmacist is not required for dispensing the drug. If this provision can be extended to majority of the products like cough and cold preparations, pain management tablets/creams, vitamin and mineral products, health supplements etc, they can be allowed to be kept and sold at any shops without an exclusive drug trade license and other conditions.

According to sources at CDSCO, the Drug Controller General of India (DCGI) had convened a meeting of the drug control officials and the drug experts to have a consensus in this matter. However, no serious decision could be taken as the officials were divided over the subject, as they believe that awareness about drugs among the people is very poor in the country.

At the same time, the industry sources said that there was stiff resistance from the CDSCO and Health ministry to open up the market for OTC products. Currently the government is thinking seriously of extending the scope of restricted licensing and providing exemptions for more drugs under Schedule K.

At the same time a number of drug companies are aggressively planning exclusive OTC divisions to promote their products with consumer marketing strategies.