The Pune division of the Food and Drug Administration (FDA) has decided to serve a show cause notice to the public sector utility Hindustan Antibiotics Limited for violating norms with regards to drugs close to their expiry date.
FDA’s joint commissioner ST Patil told DNA on Tuesday that the company distributed 18,486 vials of Haxone (500 mg) injections to different medical practitioners, after withdrawing them from the market, as ‘physicians’ samples’ just prior to the expiry of the vials in September 2010.
“Under the FDA norms, it is mandatory for all pharmaceutical companies to give prior intimation to the department before undertaking such an exercise. But HAL did not inform the FDA. We are in the process of issuing a notice seeking an explanation,” Patil said.
Last week, the FDA undertook inspection of the HAL godowns for two days following exclusive reports by DNA about the expiry of a large quantity of drugs within the factory itself. (Hindustan Antibiotics bleeds as drugs expire in godowns, July 20).
Another report by DNA on July 23 (PSU’s denial contradicts the truth) highlighted the minutes of a HAL meeting on November 24, 2010, 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 few products worth Rs1.5 crore have completed their expiry. These products are to be recycled to minimise loss.”
Significantly, these minutes were prepared by HAL’s personnel manager Trilochan Das who, on Thursday, issued a statement contesting the DNA report and contradicting his own minutes and other company documents, such as the Finished Good Status report (December 15, 2010) and Physical Stock Verification report (September 13, 2010).
On July 25, Das once again issued a clarification denying the minutes bearing his signature or that there was any discussion regarding “the recycling of expired drugs”.
“Under the 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.
