Written By: Nirmalya Dutta | Updated : June 4, 2013 11:45 AM IST
Ranbaxy's actions has put a dark shadow on India's image of being the 'Generic Capital of the World' and has got the government defending its lucrative generic drug industry as 'safe and tightly' regulated. The government went on to to say that the 'isolated reports' of spurious drugs found in global markets allegedly from India were desperate attempts by other countries to malign the fast-growing Indian pharma industry.
'Pharmaceutical sector is a highly regulated one and exports are heavily guided by various regulatory regimes of the importing countries', the government said in a statement. Drug exports totalled $14.6 billion in the financial year to March 31, marking growth of nearly 11 per cent from the previous year. Even as the government was defending its stance, a statement from Dr Reddy's Laboratories (another big Indian pharma) claimed that a mutual agreement to make generic drugs between Dr Reddy's Laboratories and Japan-based Fujifilm Corp had been called off. They gave no reason for the decision to abandon the plan for the Japanese market formulated two years ago.
For long Indian generics have been hailed all over the developing world as the key to fighting diseases like TB and HIV/AIDS in countries which can't afford the exuberant prices charged by big pharmaceuticals from the developing world. Generics to treat diseases like cancer, TB and AIDS have in recent times gained immense popularity and even the Indian government has made its position clear by refusing to hand out a patent to Novartis for its cancer drug and for refusing to stay the compulsory license given to NATCO to replicate Bayer's Nexavar. Also read: India vs Big Pharma
The country 'has proven international quality standard capabilities', the government said. 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.
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.
