Ghulam Nabi Azad

Ranbaxy facilities in India are being reviewed after its US arm, Ranbaxy USA admitted to manufacturing certain drugs which didn’t follow the rules of ‘good manufacturing practices’ and were considered ‘adulterated’ under USFDA law, Health Minister Ghulam Nabi Azad said.

The Minister was replying to a query in Rajya Sabha on steps taken by the government to ensure that ‘adulterated’ drugs are not sold in India after Ranbaxy USA Inc admitted in the US District Court of Maryland to manufacturing and distribution of certain drugs not in conformity with GMP. The Drugs Controller General of India has been ordered to review facilities of Ranbaxy in the country to ascertain the quality of drugs manufactured for domestic market, he said.

Ranbaxy USA agreed to pay a whopping $500 million and pleaded guilty to three felony counts under the federal Food, Drug and Cosmetic Act (FDCA), and four felony counts of knowingly making material false statements to the Food and Drug Administration (FDA), it said.

Azad, in a written reply in Rajya Sabha, said, ‘The Drugs Controller General of India has already been ordered to review the GMP compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities.’  The Minister said the Supreme Court of India has not admitted the PIL against the company.

‘As per the US Law, any drug is considered adulterated, if it is not manufactured, processed, packed, etc in conformity with the Current Good Manufacturing Practice (CGMP) regulations of the USFDA. However, as per Drugs & Cosmetic Act & Rules, in India, manufacturing of drugs not in conformity with Good Manufacturing Practice (GMP) is viewed as non-compliance to GMP under the said Act & Rules,’ he said. 

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. After these events, 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