The Union health ministry will soon amend Rule 64 of the Drugs and Cosmetics Rules, 1945 to make only registered pharmacists eligible to become wholesalers dealing with pharmaceutical products in the country. However, the new rule will not be applicable to the persons already registered prior to the date of final notification in this regard by the ministry.

The Rule 64 of the Drugs and Cosmetics Rules, 1945 prescribes conditions to be satisfied before a licence for wholesale is granted or renewed. Under the Rule 64, the licence for wholesale is granted or renewed to a competent person who (clause a) is a registered pharmacist, or who (clause b) has passed the matriculation examination or its equivalent examination from a recognised board with four years‘ experience in dealing with sale of drugs, or who (clause c) holds a degree of a recognised university with one year's experience in dealing with drugs.

According to sources, the Drugs Technical Advisory Board (DTAB) has now recommended to the Union health ministry that the clause (b) and clause (c) of the Rule 64 of the Drugs and Cosmetics Rules, 1945 may be deleted. However, a protection clause may also be provided that the academic qualification shall not apply to the persons already registered prior to the date of final notification.

Earlier, the proposal to amend the above rule in regard to qualification of the competent person was considered by the Drugs Consultative Committee (DCC) of the Union health ministry in its 48th meeting held on July 24, 2015. The DCC recommended that the provisions under clause (b) relating to the qualification of matriculation examination may be deleted. The members were of the view that time has come when the drugs should be handled only by the trained pharmacists who are qualified to handle drugs and are aware of good storage and distribution practices.