LICENSE FOR WHOLESALERS

The Union health ministry is reported to have decided to amend the Drugs & Cosmetics Rules to ensure that only registered pharmacists are eligible for getting licences for conducting wholesale trade in pharmaceuticals. The decision is subsequent to a Drugs Technical Advisory Board’s recommendation to delete clauses (b) and (c) of the Rule 64 of the D & C Rules empowering state drug administrations to issue wholesalers licenses to only registered pharmacists henceforth. The new rule may not be applicable to the persons already having licenses prior to the date of final notification of this change by the ministry. The move to amend the Rule 64 specifying the qualification of the person to handle medicines in a wholesale establishment was already cleared by the Drugs Consultative Committee attached to the Health Ministry in July, 2015. 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 considered ideal that they also know about scientific storage and transportation practices of various drugs and other medicinal preparations to preserve the potency. Currently these practices are not strictly followed in India by most wholesalers during extreme summer months.

Now, most of the wholesale traders are opposing the health ministry’s move on the contention that they are not directly dispensing medicines to the patients. Therefore, the decision of the ministry to make registered pharmacists as the competent persons to run wholesale shops is unnecessary. They feel that the health ministry’s move is totally against the reality prevailing in the country especially when there is an increasing resistance among qualified pharmacists to take up jobs in the pharmaceutical trade. A section of the trade however has a different viewpoint. According to this group, a pharmacist is considered to be the competent person to deal in medicines in India as per the D&C Rules. So, there has to be a legislation to make it mandatory for only qualified person eligible for grant of drug licenses even for wholesale business in future. Mandating registered pharmacists in wholesale business will ensure proper handling, storage, preservation and quality assurance of all medicines and medical devices at wholesale and distribution points. But, getting a pharmacy graduate to handle wholesale or retail trade at the current level of salary offered by the trade is not that easy. Therefore health ministry needs to give some time to wholesalers to comply with the new rule. At the same time a way needs to be found to set a salary scale for pharmacists working in trade in the country at the earliest
There can be a Wholesale License for storage of the medicines at a controlled temperature. But a Pharmacist to be present all the times is meaningless. What will he do if the wholesaler do not comply with the storage condition? 

And same system of lending the licenses for few thousand of rupees will continue even in wholesale as is the case with retail medical shop. In today's era, a pharmacist is not required to sell medicines. There is no compounding or dispensing happening at all. It is only the sales of packed and labelled medicines.

Govt.decision is the public interest ,since wholesale trade is not only dispensing or distribution of medicines,but it includes storage of life saving medicines also. For proper storage prior to actual sale/distribution supervision by a skilled /experienced person is needed ,and for this purpose service of registered pharmacist is necessary . 
Moreover for being a registered pharmacist graduate in pharmacy is not needed,but diploma in pharmacy is sufficient. Diploma pharmacist are available in plenty. 
Secondly such amendment is in the interest of trade also as such legal barrier will make entry of new wholesalers somewhat difficult and thus ease the fierce competition in trade.