FDA to launch prosecution against 77 Medical Stores

The department has initiated action against these medical stores and started investigations which will be completed in 80 to 90 days.

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FDA

Last Updated on October 8, 2021 by The Health Master

The Tamil Nadu Drugs Control Department is gearing up to launch prosecution against 77 medical stores belonging to all districts in the state for violation of conditions of licences. The actions are mainly taken against sale of psychotropic substances without prescriptions.

The department has initiated action against these medical stores and started investigations which will be completed in 80 to 90 days.

With crystal clear evidence, the department will file prosecution cases against the medical stores as per Rule 65 (9) (a) of the drugs and cosmetics rules 1945, S Sivabalan, director of the drugs control department informed.

“The cases will entail other rules also for charging after the investigation. Because, only after the investigation we will know the additional contraventions, so the cases will be charged accordingly.

We have to gather evidence before launching prosecutions. Normally, Rule 65 (2), 65 (3), 64 (3) (1) are the ones considered for contraventions. But, Rule 65 (9) (a) is compulsory,” he told.

The state wide operation was carried out following a tip-off received by the directorate last month that habit forming drugs were sold through medical stores without prescriptions. The director said raids were conducted in all the 42,000 medical stores in the entire state. The raid continued for three days from September 29.

In Chennai alone, the enforcement officials initiated action against 18 medical stores and the same number of retailers is likely to face prosecutions, it is learnt. After Chennai, more raids were conducted in Coimbatore district where 2,000 shops were inspected.

A senior officer said apart from retailers, the premises of wholesalers in Coimbatore will be targeted in the next phase of raids.

The major violations found were sale of habit forming drugs without prescriptions, non-maintenance of records in premises, sale without issuing bills and sale of H1 drugs without registered pharmacists.

The director said a second phase of raids will be conducted in the last week of this month or in the first week of November.

An officer involved in the raid in western districts said his team targeted mainly psychotropic pharmaceuticals made of tapentadol in various brand names. All these products are manufactured by major players and marketed by some leading marketing companies.

Rule 65 (9) (a) says that any substance specified in Schedule H or Schedule X shall not be sold by retailers except on prescriptions of registered medical practitioners. Those who contravene this rule will be liable for punishment for a minimum term of imprisonment and to a minimum amount of fine.

How to obtain retail drug license, click here

How to obtain Jan Aushadhi License, click here

How to change pharmacist at medical store, click here

Good storage practice of medicines at Medical Store, click here

Record keeping for Medical Store / Pharmacy, click here

Self inspection of Medical Store :105 points, click here

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