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Drug maker Ranbaxy Laboratories’ Toansa factory will soon be inspected by domestic regulatory authorities to assess whether there are deviations under the Indian law, Drug Controller General of India (DCGI) GN Singh said.
“I have already instructed my inspectors to conduct a detailed inspection of the Toansa facility. They will immediately write to the company and may visit the factory this week itself,” Singh told Business Standard. Action will be taken against the company if there are violations of the norms prescribed under the Drugs and Cosmetics Act, according to the DCGI.
The drug controller has also ordered collection of Ranbaxy drug samples from across markets. These will be sent for testing in government laboratories to check the quality and efficacy of drugs.
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The move comes in the wake of US Food and Drug Administration (US FDA) banning Ranbaxy’s factory at Toansa, which used to supply around 70% of the active pharmaceutical ingredient (API) used in products manufactured by the company. This was the fourth Indian facility of Ranbaxy to face ‘import alert’ by US authorities, after its newly commissioned formulation making facility in Mohali (Punjab) was barred in September 2013. Ranbaxy’s two more key formulation manufacturing factories at Paonta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) are already under US FDA ban since 2008.
Ranbaxy is one of the major suppliers of generics to Indian market. According to the latest sales data of IMS Health, a market research agency, Ranbaxy ranked fifth in the domestic market during December after clocking a sales of Rs 256 crore during the month. The domestic pharma market clocked a total sales of Rs 6,679 crore during December. For the fiscal 2012-13, the company was the fourth largest supplier in the domestic market with a market share of 3.9%. The largest was multinational drug maker Abbott with 6.7% followed by domestic players like Cipla and Sun Pharmaceuticals, who commanded a market share of 4.9 and 4.6%, respectively. The domestic pharma market is pegged at around Rs 79,000 annually.
A few months ago, following the US FDA’s enforcement on Ranbaxy’s Mohali facility, the domestic drug regulator had inspected various Ranbaxy facilities including Paonta Sahib, from where the company supplies medicines to the Indian market. When asked whether it found any violations during those inspections, Singh said, “There were minor violations. We had issued show cause notice to the company. They responded saying they are taking remedial measures”.
During its recent inspection of Ranbaxy’s Toansa based API factory, the US FDA inspectors found flies in the storage room, drug samples under a stack of blank paper, melting ice in refrigerator storing samples, and various data integrity issues such as over-writing of electronic data files and employees signing documents with back-dating etc. The US regulator’s observations in Ranbaxy’s Mohali facility last year also included various serious deviations such as presence of embedded hair, oil spots on tablets etc.
However, the domestic regulator maintains that it has so far not found any serious deviations under the Indian law to ban supply of medicines from these facilities.
On Monday, shares of Ranbaxy closed at Rs 310.25 on the Bombay Stock Exchange, down 7.8% from their previous close.
