The Supreme Court Tuesday issued notice to Kerala on a petition challenging a law that requires private clinics that dispense medicines to patients to obtain licences.
The court was hearing a petition filed by Indian Medical Association against the Kerala government’s decision to amended the provisions of the Drugs and Cosmetics Act 1940.
The Vacation bench of the Supreme Court headed by Justice Deepak Verma and Justice K.S. Radhakrishnan issued the notice after senior counsel V. Giri told the court that the enforcement of the amended provision of the act, were jeopardizing the functioning of these clinics.
He said that most of these clinics were located in rural or semi-urban areas and were economical for the patients as they give medicine only for the period for which it has been prescribed.
The senior counsel said that normally at chemist shops a patient is forced to buy more medicine than he actually requires because one has to buy a strip of tablets even though he may not be requiring a large quantity of pills.
Giri said that by their training the doctors of these clinics know pharmacology and need no licence to sell any medicine.
Justice Verma pointed out that the petitioner IMA was talking about the ‘small clinics in rural or semi-urban areas but in fact most of the petitioners were big hospitals’.
He said that generally in such small clinics one of the doctors is a qualified person and others are quacks.
When Giri tried to say that such things don’t happen in Kerala, Justice Verma said: ‘Kerala is also a part of India.’
Appearing for the Qualified Professional Medical Practitioners Association, counsel Purvish Malkan said that the private medical practitioners are exempted under the Drugs and Cosmetics Act from obtaining licence for treating their patients.
He told the court that private doctors cannot be equated with big hospitals in order to cover them under the provisions of the act.
It is enough to read out , in the court , the section 5 uder Schedule K and the Rule 65 (5)(i), viz. R 65(5)(i)(a) & (b) in the drugs and cosmetics acts and no arguments required if the respected judge can under stand english language.
The Drugs & Cosmetics Act & Rules do not discriminate hospitals – Govt., Private, Corporate, etc., and registered Medical practitioners. Drug stores are managed by Registered Pharmacists and hospitals by Registered Medical practitioners. The ownership is not questioned at both the places.
D&C Act, 1940 is a central Act and every state has a Drugs Control Department to to implement the act and rules.
The Drugs Control Department issue license to eligible one to manufacture or sell medicines. The most important condition in all licences for sales, be it whole sale or retail, is to honour the prescriptions of the registered medical practitioners and to supply all the medicines required for hospitals. It is also the duty of the Drug store to maintain the records of sales to all hospitals for a period of time and submit it before Officials of the Drugs Control Department when required. From this it is clear that a Drug License is not required for RMPs and hospitals.
As per the D&C Act, the DC Dept. has every right and vast powers to inspect all places where drugs are stored, including hospitals and houses and take appropriate actions. The only requirement of an RMP and hospital is that they must purchase the drug in their custody only from licensed Drug stores and must maintain the bills of purchase. The Drug Inspectors can take samples from the hospitals and if found spurious, the hospital is not responsible if there is a genuine purchase bill. It is the duty of the drug store which supplied the medicine to answer the questions of the Inspector.
Ignoring all these facts, some officers in Kerala Drugs Department, by misinterpreting Clause 5A in Schedule K, INTERESTINGLY, directed the Association of Druggists and Chemists in Kerala not to issue drugs to hospitals without a Drug License. The association that questioned the Drugs Controller was ignored and wanted to implement the dictates of the concerned Officer through the backdoor. The Rule quoted was “Rule 65 (5) (i) to impose the license on doctors and hospitals. It is unfortunate to note that no one bothered to read the additional clauses to Rule 65 (5)(i), viz. R 65(5)(i)(a) & (b).
The ulterior motives of the officers in the department is clear and by imposing license they directly get 5000 new places to grease. More in our website.