The Union health ministry's proposal to amend Drugs and Cosmetics Rules, 1945 to make only registered pharmacists as competent persons for grant of new wholesale drug licence has come in for severe opposition from the All India Organisation of Chemists & Druggists (AIOCD), an umbrella body of drug wholesalers and retailers in India.
AIOCD, representing 2.5 lakh drug wholesalers in the country, has termed the health ministry's proposed move as unreasonable and vexatious which will put livelihood of existing drug wholesalers who are mostly non-pharmacists at risk.
The draft notification on Drugs and Cosmetics Rules, 1945 amendment appeared in the Gazette of India, part II, Section-3, Sub-section(i) No.890 dated December 28, 2016 proposed to substitute clause (ii) in the second proviso of Rule 64(2) of the Drugs and Cosmetics Rules, 1945.
According to the proposal, once the amendment is made the wholesale licenses will be issued to a competent person who is a registered pharmacist. However, the proposal states that the person already registered with the State Licensing Authority as competent person for the purposes of grant of license in Form 20B or Form 21 B or both prior to the coming into force of the Drugs and Cosmetics (Amendment) Rules, 2016, shall continue to be considered as a competent person for the said purposes.
It means once for all 10th pass with four years experience or graduates with one year experience can no more be registered with the State Licensing Authority as competent person after this amendment and hence not eligible to get wholesale licence.
AIOCD general secretary Suresh Gupta said “The proposed changes will have adverse impact on livelihood of lakhs of wholesale druggists in the longer run. As of now shortage of pharmacists in several north and north east states including Uttar Pradesh, Bihar, West Bengal, Jharkhand, Assam, Punjab, Uttaranchal, Haryana and Jammu and Kashmir, Orissa has delayed licence renewals of retail drug stores. Given the shortage of pharmacists at retail level, it is irrational to consider only registered pharmacists for grant of new wholesale drug licence.”
Gupta said that the government has not yet clarified that when it comes to renewal of licences, will wholesale druggists be allowed to renew their licences in absence of pharmacy degree. In future the existing wholesale druggists, if they are not pharmacists may not be allowed to renew their licences. The move will result in punishing lakhs of wholesalers without any reason.
AIOCD has directed to its affiliated associations in states to write to Prime Minister's Office and Health Ministry opposing the government’s proposed amendment to Drugs and Cosmetics Rules, 1945. We are also going to submit a memorandum to the concerned ministry seeking revocation of the move, he added.