India to Soon Define a Category for Over-The-Counter Drugs

To bring more opaqueness in the concern of which drugs should be permitted to sell without a prescription, a committee of apex drug regulator has concluded to create a separate category for over-the-counter medicines.

And if the proposal is granted by the advisory board, the country will at last define OTC drugs and probably limit the sale of those medicines which shouldn’t be sold without prescriptions. Simultaneously, health activists believe that even if the decision is approved, it won’t have much impact, until the policy to depress the retailing of harmful drugs without prescriptions are enforced and strengthened.

The CDSCO (Central Drugs Standard Control Organization) is anticipated to modify regulations on cosmetics and drugs to comprise a split list for OTC drugs. In a meeting, drugs consultative committee waved a green flag for creating a category, which will have an inclusion of medicines for colds, allergies, minor illnesses, and fever.

The official stated that the sub-committee of CDSCO was already functioning on the list. Drugs such as contraceptive pills, cough remedies, and paracetamol might be included in it. The country already has a defined drugs policy that mandates a prescription to be sold, but the policy does not indicate what all drugs can be sold and what cannot.

“Once the catalog for the OTC is created, the pharmacists would be lawfully permitted to hand out medicines devoid of prescriptions. Most prominently, the list of OTC will have details of which medicines are presently excluded from the prescription needed categories and can be sold over the counter,” said an official.

“Normally, people assume drugs that aren’t in Schedule H, H1, X, etc. don’t need a prescription. Now the supervisory body will catalog independently which drugs can be delivered without prescription.

Indian Medical Association’s president KK Aggarwal stated that around the world, there is a separate definition of OTC drugs but India does not have any such differentiation for the same.

He also stated that unscheduled drugs don’t need manufacturing or selling license. And if the government is planning to implement such policies, it will be most welcomed. There is a necessity to create a regulation to avoid the misuse of the drugs. However, the whole effort might go impacted if the regulators don’t impose penalties for those who violate the policies.

The government should also consider revision of Drugs and Cosmetics Act to precisely define strict action against the violation. As failing to do so, have so far increased the drug growing resistance issue,” he added.