The Andhra Pradesh Drug Control Administration (APDCA), which had seized drugs worth Rs.45 lakhs from Alkem Laboratories for illegally involved in changing the labels of its brand from ALCLAV-625 to ALCLAV-FC, is contemplating legal action on all the involved parties which include Alkem Laboratories Ltd, Daman, Celon Laboratories, Hyderabad and Seven Pharma Ltd, Peru.

Earlier in April 2012, the APDCA had seized drugs worth Rs.45 lakhs (250,000 numbers of ALCLAV-625 tablets) from Alkem Laboratories Ltd for diverting its export consignment - meant for its distributor Seven Pharma in Peru - to Hyderabad’s Celon Laboratories and illegally changing labels of its original brand name on the strips from ALCLAV-625 to ALCLAV-FC.

“We have booked the cases and issued notices to all involved in the issue. As we have gathered sufficient evidence to prove their misbranding activity which attracts section 18 (c), Section 17 and 17-B of the Drugs and Cosmetics Act, 1940, legal action will be taken against all the defaulters and will be punished accordingly,” said RP Thakur, director general, APDCA.

It is believed that Alkem knowingly allowed misbranding of its tablets at the behest of Seven Pharma, through Celon Laboratories in Hyderabad, which is sister-concern of Seven Pharma.

According to reliable sources, Alkem Laboratories Ltd. at Daman used to supply ALCLAV 625 tablets to its distributor Seven Pharma in Peru. But last year in January 2011 the registered period for the drug in Peru got expired, so Seven Pharma re-registered the same drug with a slightly modified name ALCLAV-FC with the local authorities in Peru.

Intimating the same, Seven Pharma requested Alkem to manufacture ALCLAV-FC in place of its earlier brand ALCLAV-625 mg so as to comply with its registered name in Peru. Investigators revealed that though Alkem initially agreed to Seven Pharma’s request and even put an application at DCA Daman for registering the new brand name, but due to unknown reasons the company never registered the new name as suggested by Seven Pharma.

Alkem again started supplying the same branded tablets to Seven Pharma which led to a tussle between the two companies, but eventually both of them came to an agreement and sought the help of Celon laboratories Ltd in Hyderabad to erase the original label of ALCLAV 625 mg on the strip and re-print it with the changed brand label ALCLAV-FC.

Sources revealed that managing director and vice president of Celon Laboratories were involved in receiving the stock of 50,000 tablets of ALCLAV-625 mg at the behest of B Murali Krishna Reddy and K Rami Reddy, directors of Seven Pharma in Peru.

It is believed that Seven Pharma with the help of Celon Laboratories even took an unlicensed premises at Gacchibowli for the activity of alteration of the labels and it is also said that directors Rami Reddy and B Murali of Seven Pharma were involved in getting the printed packing cartons of ALCLAV-FC at Intech Printers, a printing press owned by K Ravinder of Celon labs.

Sources said the video clippings clearly showed the entire labelling system where the original strips were first applied with a liquid chemical to erase printed ink of the original brand label and again re-printing it carefully with a changed brand label with suitable coloured ink without actually disturbing inside contents of the strip.

The investigators from the DCA said, “We have got clear evidences regarding Alkem’s role for sending the stock by air from Mumbai to Celon Laboratories in Hyderabad for the purpose of alteration of the brand name from ALCLAV 625 to ALCLAV-FC.”