QPMPA approaches President of India on issue of drug licences to run hospital pharmacies
The Central Drugs Standard Control Organisation (CDSCO) has invited the Qualified Private Medical Practitioners Association for a detailed discussion and interpretation of the clause in item 5 of the Schedule K of the Drugs & Cosmetics Act (D&C Act). This follows a letter sent by the Association to the president of India on this matter.
Desperate after losing a case in the supreme court after 21 years of fight in the high court of Kerala, the QPMPA, Kerala Branch in a letter to the President Pratibha Devi Singh Patil, mentioned that due to the ignorance of the bureaucracy one clause in item 5 of Schedule K in the D&C Act 1940 and Rules 1945 is misinterpreted and needs amendment.
The Act does not demand private hospitals to obtain drug licences to run their pharmacies attached with them. But, the drug control officials in Kerala insisted the doctors to take licences for their pharmacies. Since the Act is written in English language, perplexity persists in the meaning of one sentence which is being used as a weapon by the drug control authorities to pester the private hospital establishments under the pretext of drug licence, the letter alleged.
The doctors association has requested the president of India to initiate corrective measures to save the D&C Act and Rules without being misinterpreted by certain regulatory officials. According to them, section 6.3 of Medical Ethics does not permit doctors run or open drug shops.
The CDSCO in a letter to the QPMPA has asked them to submit all the letters the association had sent to the President’s office and to other constitutional bodies, and the copies of their monthly journal. Dr K Kishore Kumar, secretary of the QPMPA had sent letters to, besides President of India, the Chief Justice of India and to the chairman, National Human Rights Commission.
In the letters to the constitutional bodies, the secretary said even the advocates who were engaged by him to argue the case also did not properly grasp the inherent meaning of the clause, hence he could not win the case. So the confusion over the meaning of the clause has to be avoided through an amendment with correct language.
According to Dr Kishore Kumar, after the dismissal of the SLP (C), No 6877/11 on 18.3.2011 by the supreme court , the drug control department has given wide publicity and forced all the private hospitals in Kerala to take drug licences.
The Kerala High Court in its order of March 25, 2010 had mandated all pharmacies attached to private hospitals in Kerala, either for dispensing or for stocking drugs, to obtain licences from the drugs control department. Against this verdict, the QPMPA filed a review petition in the high court which was dismissed later. After that, the doctors association approached the Supreme Court which also did not give them a relief.
Since all the doors are closed before the QPMPA, it has, at last, approached the supreme head of India with a request to rewrite the Act itself.