AIOCD writes to Union Min over misuse of Schedule K Drugs and Cosmetic Rules

CHENNAI: The All India Organisation of Chemists and Druggists has written to the Union Minister of State for Health and Family Welfare, over alleged misuse of exemption given under Schedule K Drugs and Cosmetic Rules, dating back to 1960, which allows the sale of medicines at the place of a medical practitioner, without a license or a trained pharmacist.

The amendment made to the Drugs Act of 1945, has outlived its utility and is now being misused by a section of the medical practitioners who hoard medicine and sell them to their patients as well as resorting to over-the-counter sales, risking the lives of the public, the association said in the letter. The association also flagged how fake doctors and practitioners of other forms of medicine, including Homeopathy, take shelter under the exemption given in para 5 and 5A of the Schedule K Drugs Act, making its review need of the hour.

Provisions of para 5 and 5A allow registered medical practitioners and hospitals to stock and use medicine for their patients at their premises without a requisite license or employing a registered pharmacist. The association says the amendment made sense in the 1960s when there weren’t enough trained pharmacists to supervise the sale of medications. Also, there was a dearth of medical stores at that time, making it tough to source medicines, that’s why doctors were allowed to sell medicines at their premises, the association said in the letter.

Nowadays almost all medicines are available in tablet or capsule form and are freely available through pharmacies, making the 1960 amendment irrelevant, the association said. They pointed out the dangers of allowing doctors to stock huge quantities of medicines and sell them at their will without proper supervision. The association appealed for a review of the Schedule K amendment and the deployment of more drug inspectors to stop violations.

“The schedule K exemption applies only to the allopathy doctor who is personally prescribing medicine to his patients, based on a diagnosis. All other requirements of Rules 64 and 65 apply to doctors and hospitals too, but it is seen that these provisions are grossly violated. They are not keeping mandatory records, and are selling medicines without bills, evading tax,” read the letter.

President of the association, JJ Shinde, claimed that on the premises of the doctor, unqualified attendants are selling medicines to the patients, which is very harmful as they aren’t trained for it.