Maharashtra FDA suspends two drug licenses of Dr Reddy's

The Maharashtra Food & Drug Administration (FDA) has issued an order to suspend two 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 found at the company’s storage premises situated at Bhiwandi near Thane.

The FDA assistant commissioner and licensing authority G K Vakharia in his order released on November 19, 2014 has suspended two drug licences bearing no 20B/TNZ-5/1737 and 21B/TNZ-5/1738 for the period January 12 to February 10, 2015 under rules 66 (1) and 67 (H) of the Act. Vakharia observed that the samples of hand wash or hand sanitizer were found to be fake and the quantity and there were no numbers on bills.

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.

Vakharia told Business Standard: “'The order to suspended Dr Reddy's Laboratories two drug licences has been issued in the larger interest of public health. During inspection by the FDA officials, it was found that the company was not serious to strictly follow the provisions of the drug licences.”

Dr Reddy’s Laboratories has appealed to the state department of medical education and drug with a plea 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”.
The company officials along with its legal counsel on Tuesday met FDA minister Girish Bapat with a fresh plea to stay the FDA's suspension order. Bapat has sought the details from the department.

A Dr Reddy's Laboratories spokesman said, "The order relates only to the wholesale license of the clearing and forwarding agent. In our opinion there has been no violation of any statute or regulation by the company. The product being investigated is not a drug and is neither manufactured nor marketed by us. The order has been appealed and its stay petition is pending."

The company in its petition also said the ''Bdel Plus'' hand wash or hand sanitizer found at the premises was not its ''Emlukast-FX'' drug. 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 company thereby was not liable for any statutory declaration of the product and thus had not violated rule 65(5) (1) of the Drugs & Cosmetics Act, 1940.

The company explained that ''The Appellant's licenses are used to sell, stock or offer for sale or distribute the wholesale drugs from its Bhiwandi premises. The products being distributed through medical representatives are promotional items  and not for sale. As in the ordinary course of pharma business promotions to doctors, we provide these promotional items for their in-clinic use and the promotional items are being provided through our field staff.'' 

As far as the maintenance of the stock transfer notes, the company clarified that the company does not purchase any stocks and therefore documents issued in this regard is the stock transfer note. 

''We would like to inform that 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 added.

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