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Written By: Admin | Updated : June 7, 2013 12:02 PM IST
The DCGI will complete its preliminary examination into the charges that Ranbaxy pleaded guilty to in the US and whether those infringements have any ramifications in India, health secretary Keshav Desiraju told the Economic Times in an interview. He said that that the government wasn't underestimating the significance of the USFDA decision but knee-jerk decisions would be bad in such a sensitive case. He added that the preliminary examinations would take a month.
Apollo Pharmacy suspends sales
In another blow to Ranbaxy Laboratories, the country's biggest drug retail network Apollo Pharmacy has suspended the sale of medicines manufactured by Ranbaxy Laboratories and it has also stopped procuring drugs from the company as of now. 'Our medical committee, which is a very strong committee within Apollo, has reviewed the matter and recommended, as a cautionary measure, we should temporarily suspend sale of Ranbaxy medicines, as we cannot take a chance with patients' safety. So, we have immediately issued an advisory to our pharmacies,' Apollo Hospitals Executive Director Shobana Kamineni told Business Standard.
She added that Apollo has sent a questionnaire to Ranbaxy seeking further details including re-certification of current stock and reports for other medicines. 'We have nothing against Ranbaxy but we must respect what our medical committee has ordered We have asked them (Ranbaxy) to re-certify whatever stocks we have now. We have also asked for test reports of all those drugs and a bunch of other details,' Kamineni said, adding Apollo's pharmacies would restart sale of Ranbaxy drugs after the company had fulfilled the requirements and satisfied the medical committee.
The Ranbaxy story till now
The Ranbaxy episode started in September 2008 when the USFDA issued two Warning Letters to Ranbaxy Laboratories and import alert for generic drugs produced at two different plants. However, in June 2008, Daiichi Sankyo, a major Japanese company had procured a majority in Ranbaxy in a deal believed to be worth $4.6 billion dollar. A fortnight ago, Ranbaxy offered to pay a $500 million fine for selling adulterated drugs and pleaded guilty to seven criminal counts including fudging of data, intention to defraud and failing to report that its drug didn't meet specifications. Since then a lot of dirty linen has been washed in public with the Japanese company accusing the Singh brothers the former owners of Ranbaxy of concealing and misrepresenting critical information regarding the USFDA investigations. Malvinder Singh, the former Chairman however eschewed all guilt and claimed the Japanese company had mismanaged the company. He said, 'There was no misleading Daiichi approached us when they came, US FDA investigations were on. They knew about it and it was public information. So there was nothing that was hidden. Whatever they wanted and asked for was shown to them. They did a due diligence. Who would risk $5 billion without a due diligence?'
Meanwhile the Drug Controller General of India (DCGI) Dr GN Singh said that all the approvals given to Indian drugs manufactured by Ranbaxy Laboratories were in order. As per the laws, there was no indication of any company violating the Indian laws, including Ranbaxy. However, Dr Singh admitted that all matters including approvals in the past would be examined again. Dr Singh added that appropriate action would be taken and a special team would be set up to examine the case. They would send officials to the US if the situation demands it. 'My most important concern is to assure the safety and efficacy of the drugs in India and action will be taken as per the Drugs and Cosmetics (D&C) Act, not just against Ranbaxy but other companies also if found guilty,' Dr Singh told Pharmabiz. Recently, Jaslok Hospital became the first one to ban Ranbaxy drugs and the Indian Medical Association asked the Drugs Controller General of India (DCGI) to investigate the quality of drugs sold by Ranbaxy Laboratories in India.
The Ranbaxy issue evoked a strong response from the government which said that the country 'has proven international quality standard capabilities'. India enjoys 'a unique position of low-cost manufacturing and the highest quality medicine, the best of both the worlds', the statement added. It invited global importers to visit factories to 'satisfy themselves of the quality of production of drugs'. There's a school of thought which believes that all the complaints about generic medicines originate from Big Pharma with big brands unhappy with the growing use of cheap generics, as developed nations fight to lower healthcare costs. Also read: India vs Big Pharma
