Drugs Technical Advisory Board is reported to have recommended to the Union Health Ministry last month the clauses (b) and (c) of the Rule 64 of the Drugs & Cosmetics Rules may be deleted to empower state drug administrations to issue wholesalers licenses to only registered pharmacists henceforth. The proposed rule will not, however, be applicable to the persons already registered prior to the date of final notification of this change by the ministry. The proposal to amend the Rule 64 specifying the qualification of the competent person to handle medicines was already considered by the Drugs Consultative Committee attached to the Union Health Ministry in its meeting held in last July. The members of the DCC are of the view that time has come for drugs and other medicinal products to be handled only by qualified and trained pharmacists having knowledge of good storage and distribution practices. Although pharmaceutical wholesalers are not directly involved in dispensing medicines, it is ideal that they also know about scientific storage and transportation practices of various drugs and other medicinal preparations to preserve their potency. Currently these practices are not strictly followed in India by the wholesalers especially during extreme summer months.
DTAB’s recommendation and the likely decision by the health ministry, in this regard, is being opposed by the pharmaceutical trade and the associations representing the wholesalers. They have threatened to organize a nationwide agitation against the possible move disallowing trade licenses to non pharmacists. Under the Rule 64, a licence for wholesale business is issued to a person who has qualification in pharmacy or passed matriculation and having four years experience in drug sale, or a graduate in any discipline with one year experience in dealing with drugs. It is true that wholesalers, without being pharmacists, have been getting trade licenses from the drug control authorities for all these years and they have been a vital link in the whole healthcare business of the country. The traders are also of the view that the number of registered pharmacists who are active in India is not sufficient to carry on the pharma trade in every nook and corner of the country. There are hundreds of towns and urban areas in the country today without any stockists or wholesalers. The stand of the wholesalers, therefore, cannot be totally ignored considering the fact that a large number of pharmacists passing out of 2000 pharmacy colleges every year are not interested in getting into the pharma trade. If persons with the prescribed qualifications under Rule 64 can satisfactorily function as responsible wholesalers, the health ministry can reconsider its decision once again.