Near-expiry drugs become ‘physicians samples’ in Pune

The Pune division of the Food and Drug Administration (FDA) has decided to serve a show-cause notice to the public sector Hindustan Antibiotics Ltd (HAL) for violating norms with regards to drugs nearing their expiry date.

Speaking to DNA on Tuesday, FDA’s joint commissioner, ST Patil, said the company distributed 18,486 vials of Haxone (500mg) injections to different medical practitioners as “physicians’ samples” just prior to the expiry of the vials.

According to Patil, the vials whose expiry was in September, 2010, were withdrawn from the market just before expiry and distributed to doctors as “physicians’ samples”.

“The company can give physicians’ samples to doctors before the expiry date. But, under the FDA norms, it is mandatory for all pharmaceutical companies to give prior intimation to the department before such an exercise is undertaken. But HAL did not inform the FDA about it. We are in the process of issuing a notice to HAL seeking an explanation,” Patil said.

Last week, the FDA undertook inspection of HAL’s godowns for two days following exclusive reports by DNA about the expiry of large quantity of drugs within the factory itself (‘Hindustan Antibiotics bleeds as drugs expire in godowns’, DNA, July 20).

The FDA’s Patil said that following the DNA reports, the administration too wanted to seek a clarification from HAL about the references to recycling in the minutes.

“Under FDA rules, no recycling of drugs by pharma companies is allowed after its expiry. Hence, we sent a team to HAL to ascertain the details,” he said.

He said that during the inspection, the FDA team did not find any evidence to suggest that the ailing PSU was recycling the expired drugs.

It, however, found stocks of about Rs81 lakh of expired drugs stockpiled in the firm’s godowns. The expired drugs included Cepha (500mg), Amox (500mg), Procaine Penicillin Forte and Dynacil injections (500mg).

Another report by DNA (‘PSU’s denial contradicts the truth’, July 23) highlighted the minutes of a HAL meeting on 24/11/10 between the management and union representatives chaired by general manager (M&M) KP Rajan.

Among other things, the minutes recorded a statement by the manager (marketing) VP Mupade that as of November 2010, the company had an inventory of Rs10 crore “and a few products worth Rs1.5 crore have completed their expiry. These products are to be recycled to minimize loss”.

Significantly, these minutes were prepared by HAL’s personnel manager Trilochan Das, who later issued a statement contesting the DNA report and contradicted his own minutes and other company documents such as the finished good status report (15/12/10) and physical stock verification report (13/9/10).