The Maharashtra Food and Drug Administration (FDA) is planning to file a case against DRL in the court of law for supplying spurious products to doctors' clinics in violation of Section 18 (a) (1) following the administrative action recently against the company.
The regulator had earlier issued an order to suspend drug licences of Dr Reddy’s Laboratories for violation of Rules 65 (5) (1) and 65 (5) (3) (ii) of the Drugs and Cosmetics Act, 1940 for serious lapses in terms of documentation and storage at company’s warehouse situated at Bhiwandi near Thane.
The FDA assistant commissioner and licensing authority G K Vakharia in his order released on November 19, 2014 had suspended drug licences for the period January 12 to February 10, 2015 under Rules 66 (1) and 67 (H) of the Act. It was observed that the samples of hand sanitiser were found to be not of standard quality.
Further, FDA said the competent authority's full signature was missing and the short signature found during inspection of the Bhiwandi premises was not identical with the original signature of the said authority. FDA had also found fault with maintenance of stock transfer notes, saying they were not kept in the chronological manner.
Vakhariya explained, “'The order to suspend Dr Reddy's Laboratories licences had been issued in the larger interest of public health.”
Dr Reddy’s Laboratories has however made an appeal to the state medical education department stating that “If the licence is suspended then irreparable loss will be caused because the company will have to stock its drugs at other warehouses and its various products would not be made available to the stockists thereby resulting in shortage of drugs to its consumers mainly patients suffering from various sickness and diseases”.
According to FDA officials, "The product was a promotional material and meant for in-clinic use only and it was not produced by the company but by a third party vendor."
''The products being distributed through medical representatives are promotional items and not for sale. The documents verified were the stock transfer notes that are accompanied along with the products when products are being transferred from one location to another and they are not classified as sale but mere transfer between the locations for facilitating business operations,'' the company officials explained.