The Pharma Traders Association has urged the Union health ministry to remove exemption given to registered medical practitioners to stock and sell medicines under Schedule K of Drugs and Cosmetics Rules, 1945.
As per entry 5, under Schedule K of Drugs and Cosmetics Rules, 1945, a registered medical practitioner is allowed to stock and sell the drugs to his patients from his premises without obtaining a license for drug sale under provision of Drugs and Cosmetics Rules, 1945 and without employing a registered pharmacist.
The entry 5 was amended by government of India vide notification number F-122/59-D dated April 9, 1960 to this effect. The corresponding “extent and conditions of exemptions” shows that the same has been amended by some substitution, omission or insertion, made from time to time i.e. on September 18, 1965, September 2, 1978, June 22, 1982 and June 20, 1984. Thus it is very clear that since April 9, 1960, a registered medical practitioner is allowed to stock and sell medicines to his patients.
The reason for introduction of such exemption was probably due to drugs in the form of tablets/capsules or other dosage forms ready to consume were not available and hence practice of compounding/mixing was prevalent at those times, said Jaideep Kumar Gupta, general secretary, UP Pharma Traders Association.
The association had last week written to Union health minister Mansukh Mandaviya requesting him to take steps to remove this exemption at the earliest.
It had also dashed off a letter to the Drug Controller General of India and Food Safety and Drug Administration Department, Uttar Pradesh and Pharmacy Council of India in this regard.
“Over the years Indian drug industry has grown in a big way and today it has established itself as a world leader, in its own way. Because of this advancement in the drug manufacturing area, “ready to consume” drugs in various dosage forms are easily available, we should have long ago omitted this exemption and should have encouraged doctors to serve the patients by indulging in clinical practice alone,” said Gupta.
Contrary to this, what we see as on today, is that number of doctors, particularly from small towns and villages, are making mockery of this exemption given to them under provision of Schedule K and practically they are running a medical store in their dispensary by stocking huge quantity of medicines, thereby flouting the principle of ethical medical practice, he added.
At the same time, they are not allowed by the government as per recently made rules to run a medical store. Since there are plenty of medical stores available in the vicinity of dispensaries, the said exemption has lost its necessity, automatically. This provision of exemption under Schedule K has in fact made the provision of not running a medical store by a doctor, a redundant one, he pointed out.
Due to adoption of such unethical practices by the registered medical practitioners, the profession of pharmacy is suffering and there is unrest in the fraternity of pharmacists. The sale of medicines by doctors has affected the livelihood of pharmacists running medical stores. Thus to bring some ethical discipline in medical practice and to save the profession of pharmacy, there is a dire need to remove this exemption as early as possible, stated general secretary, UP Pharma Traders Association.