They are directed to take steps to safely dispose of expired drugs
CHENNAI: The State Drug Controller has written to drug manufacturers, placing upon them the onus of clearing stocks of expired drugs from circulation.
In his note, he has directed them to take adequate steps to safely dispose drugs, especially those that have been returned to them. In fact, he has further extended their responsibility by relaying to the manufacturers an instruction to send a letter to their agents who procure drugs from them around the time of expiry, advising them to send the unsold drugs back to the manufacturers.
In cases where the manufacturers are not based in the State, the Clearing and Forwarding agents who represent them in Tamil Nadu are charged with this responsibility. These agents are required to have valid documents for each batch and be able to trace the supply chain down to the last pharmacy, he added.
“This way, we are fixing the responsibility on the manufacturers for clearing old stocks. Since they are the central point from which the flow begins, it is easier to monitor and supervise that group and ensure that old drugs are no longer in circulation,” P. Bhaskaran, Drug Controller, told TheHindu.
Also, at the retailer level, the office of the Drug Controller has planned interventions to prevent unqualified persons from manning the pharmacies. Legal action will be initiated against the pharmacy if it is found that persons without the required B.Pharm qualifications are serving at the counters. “A lot of such people, relatives of the licenced retailer, are now helping out in their spare time. But this is serious business, we cannot take a risk with someone who has no clue as to what they are dealing with,” he added.
The Drug Controller has also threatened to prosecute manufacturers and retailers not complying with regulations, depending on their liability and the nature of the offence itself. “We have already specified that those applying for new licences should comply with certain minimum regulations, specifically storing drugs at temperatures below 25 degrees. This requires basic cold storage infrastructure of course. Existing pharmacies are expected to bring about the changes too,” Mr. Bhaskaran said.
He also urged the consumers to inform the Drugs Controller of any unusual/adverse reactions from consuming a new drug in the market. If a statistically significant number of complaints are received, containing similar complaints, the drug controller can even recommend that it be recalled from the market with immediate effect.