According to their statement,‘Daiichi Sankyo believes that certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the US DoJ (Department of Justice) and FDA investigations,’ said a statement issued by the company. ‘Daiichi Sankyo is currently pursuing its available legal remedies and cannot comment further on the subject at this time.’

The recent incident saw an ex-Ranbaxy employee claiming that the company falsified data and annual reports submitted to the USFDA. He also alleged that Ranbaxy’s former senior leadership had ordered that evidence of data fudging and adulteration of drugs be destroyed. What makes the matters worse is the fact that even though the board members of the company knew about the misdoings, they chose to remain silent.

Daiichi Sankyo, Japan’s third-largest drug marker holds 63.5% of Ranbaxy. They had bought a stake 34.8% stake in Ranbaxy from the Singh brothers for Rs 10,000 crore in June 2008. 

Incidentally, after the deal with the Japanese company, Malvinder and Shivinder Singh went on to co-own private healthcare biggies Fortis Healthcare and Religare. 

Will Ranbaxy’s mistakes harm Indian pharma’s image?

Indian pharma has taken a big hit with the Ranbaxy episode raising questions about the efficacy and safety of the billion dollar industry. Indian generic drugs are quite popular in the US and other parts of the world but they may find it hard to secure new contracts.  Hemant Bakhru, an analyst from a brokerage firm told the Economic Times, ‘Indian companies have been under tight scrutiny since the Ranbaxy scandal broke out in 2008. We have seen that the number of inspections by USFDA has substantially gone up, and there have also been surprise visits by them; so Indian companies have been tightening their norms since then.’ 

The US generic market is estimated to be $90 billion out of which India’s share would be somewhere around 6% or $5.4 billion dollars. DG Shah, the Sec General of the Indian Pharmaceutical Association said, ‘Ranbaxy’s mistake was that it deliberately hid the fact, this is a lesson that Indian industry must learn. It must avoid this temptation of covering up wrong doing’. Though warning letters and settlements are not uncommon, what’s worrying is that Ranbaxy’s follies will tarnish India’s image as a safe drug manufacturing country. 

The company also pleaded guilty to the criminal charges of manufacturing and distributing certain adulterated drugs manufactured at its two Indian facilities and the company agreed to pay a staggering $500 million dollars to resolve false claim allegations. Experts are unanimous that these events will give Indian pharma a bad name and other companies may have to bear the brunt of Ranbaxy’s follies. Incidentally, Ranbaxy is no longer an Indian company and is now owned by Japan’s Diiachi Sankyo.

Hemant Bakhru, an analyst from a brokerage firm told the Economic Times, ‘Indian companies have been under tight scrutiny since the Ranbaxy scandal broke out in 2008. We have seen that the number of inspections by USFDA has substantially gone up, and there have also been surprise visits by them; so Indian companies have been tightening their norms since then.’ 

The US generic market is estimated to be $90 billion out of which India’s share would be somewhere around 6% or $5.4 billion dollars. DG Shah, the Sec General of the Indian Pharmaceutical Association said, ‘Ranbaxy’s mistake was that it deliberately hid the fact, this is a lesson that Indian industry must learn. It must avoid this temptation of covering up wrong doing’ Though warning letters and settlements are not uncommon, what’s worrying is that Ranbaxy’s follies will tarnish India’s image as a safe drug manufacturing country. 

On the other hand, the Indian government ‘has joined hands with the Nigerian authorities to fight the influx and has thus reduced the flow of such medicines from India,’ Jimoh added. Nigeria has been faced with the influx of counterfeit medicines over the years and has tried several methods to overcome the scourge. Last year the government proposed a bill providing stiffer punishment for organisations and individuals who may be arrested for dealing in the manufacture and sale of counterfeit medicine.

The government at the time wanted to use the bill to protect local manufacturers against inferior imports that were selling cheap on the market. It was proposed to provide support to three agencies – Standards Organisation of Nigeria (SON), National Agency for Food and Drug Administration and Control (NAFDAC) and the Consumer Protection Council (CPC) – to link their activities and work in concert. The government at the time promised to support to the organisations in the enforcement of regulations in the control of fake products. It has been revealed that NAFDAC has been able to bring the prevalence rate of fake drugs down to six percent from the 16.7 percent over the past five years.

The proposed bill, however, turned out to be much ado about nothing as there was no movement forward. Jimoh’s comments come to confirm an earlier statement by NAFDAC director general Paul Orhii that most fake, substandard and counterfeit drugs imported and openly sold on the Nigerian market were from China through smuggling with the connivance of some unscrupulous persons whose only interest is to make money.

Orhii said even though Nigeria had been doing everything possible to fight the scourge of counterfeit drugs, China had remained a problem. This is because the authorities in China have refused to show any interest to assist in the elimination of the chain that had been traced to their country. ‘India has tried to collaborate with Nigeria maximally on strategies to reduce the importation of counterfeit medicines to the country,’ Orhii said, adding: ‘But, concerning China, we are still trying to work out how to collaborate with each other. For now, without fear of contradiction, I will say that China remains the highest exporter of these fake products and China is a problem for Nigeria.’

He said the Agency was working closely with the Chinese embassy in Nigeria to track down the company in China that connived in the shipping of counterfeit medicine into this country. Orhii said the recent discovery of a huge consignment of counterfeit drugs had also revealed that these drugs were being sold in the market by those who also dealt in other products to escape the attention of the security agencies.

Expressing his determination to fight the influx, Orhii said: ‘There will be no sacred cow in the fight against counterfeit medicines. Any counterfeiter arrested will be prosecuted according to the law of the land.’

This is an indication that foreigners who hide behind the cordial relationship between their country and Nigeria to engage in negative activities will not be spared the rod. It is however not clear how the Nigerian authorities intend to deal with the Chinese diplomatic mission that doesn’t seem to be interested in helping to fight the influx of counterfeit medicine.

To achieve its aim to beat the influx, NAFDAC has also appealed to the general public, market unions and transporters to report any suspicious activities that would help it ensure that those who may try to avoid arrest were not spared but were prosecuted according to the law.

Source: IANS

What are generic drugs?

They are drugs which have the same chemical composition as branded drugs. They are sold under their chemical name instead of the branded name and are usually cheaper. There has been a movement in recent years to bolster the generic drug scenario in the country and the Govt has even promised to provide them free at public health facilities. Thanks to lack of patent laws that don’t recognise intellectual property rights, India is the leading manufacturer of generic drugs in the world and many developing countries are dependent on Indian pharmaceuticals for drugs to treat various diseases including HIV/AIDS, malaria and even cancer. They entered public consciousness last year when Aamir Khan discussed them on his reality show Satyamev Jayate. 

With inputs from IANS

‘India is capable of manufacturing 95 percent of its medicines. There is no country where Indian medicines are not used,’ he said. ‘Don’t mix patent issues with quality issues,’ he said.

World Bank representative S. Nagpal said: ‘In Africa, good quality affordable medicines are still problematica.’ Observing that his country has a huge disease burden of communicable and non-communicable diseases, Zimbabwe Health Minister Henry Madzorera said very little drug manufacturing was happening in the country.

‘We are here to learn from India. We want to be sufficient at least to some extent,’ he said. African countries account for over 17 percent of India’s medicines and fine chemicals’ export.

Source: IANS

The FDA has sought $4.7 billion from the US government and experts believe the FDA might get it even in these uncertain economic times. This fiscal it would lead to the FDA hiring more inspectors which could increase handling capacity and will lead to more approvals of generic drugs.

This is how it might pan out: the FDA has sought $4.7 billion. It is likely the US government may well allocate the amount, in spite of the current tight budget regime. And from drug-makers’ perspective, higher FDA staff could mean quicker regulatory clearances. Observers have pointed out that the FDA is understaffed, which has led to slow approval of drugs. ‘That could change for the better now. More FDA staff is good news indeed,’ said a senior official of a generic drug major.

There’s another reason for India’s newfound optimism. This fiscal, the FDA is expected to focus on China, not India, in terms of facility inspections and intense scrutiny of applications. With simmering tensions, the FDA will be inspecting manufacturing facilities in China more closely. Prior, the FDA has been inspecting manufacturing facilities across the world, including those in India. In fact, it inspected 813 facilities in 62 countries last year.

Earlier resource constraints have forced the FDA to rely on inspectors in the US.  So, certain sections of the industry fear that more FDA inspections could increase the number of warning letters. ‘But higher staffing would also result in speedier approvals,’ said a source. Indian companies are optimistic that with these new turn of events, Indian generic companies could finally make headway in the US. 

He also claimed that Cipla and Ranbaxy drugs came in handy when his foundation was trying to treat AIDS patients in the Caribbeans. ‘I told myself that never again will I come to India without saying a thank you,’ he said to applause from members of a 600-plus audience, including some of India Inc’s leading CEOs, businessmen and strategists at Kotak Mahindra’s inaugural lecture series in Mumbai.

10 years ago, drug maker Cipla sharply cut prices of HIV medicines, which transformed the battle against HIV/AIDS. The drugs sold were much cheaper than patented drugs sold by MNCs which pushed many governments of Asian and African countries to adopt generics to treat AIDS patients. Clinton’s nod comes a few weeks after the Supreme Court reinforced the importance of generic drugs by refusing to give Novartis’ leukaemia drug and the Intellectual Property Appellate Board upheld the compulsory license given to Indian pharma company Natco for Bayer’s blockbuster cancer drug Nexavar which brought down the price of the drug by 97%.

At the event, the former president criticised the current economic model which favoured capital over labour and in some cases could cause gross inequalities.  He added that India was the ultimate paradox with its huge middle class and an even greater number of who continued to live in poverty.  ‘We have to move to a level of shared prosperity for all,’ he said.

The company has the right to express disappointment. The patent, after all, has been accepted in 40 countries. But raising fundamental questions about India’s pipeline of innovation is an attempt to negate the cold fact that IM flunked the country’s sophisticated patent criteria. When the court tested IM against Section 3(d) of the Indian Patents Act, Novartis cut a sorry figure trying to pass it off as an invention. The company was found to be what is called ‘ever-greening’ of IM — a process where patent applications are filed with some ‘artful drafting’ to ensure the protection remains for a longer time.

The following, as per the sub-section, does not amount to invention: ‘The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant.’ Accordingly, the apex court observed: ‘This application leaves no room for doubt that Imatinib Mesylate marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent.’

Jurg Zimmermann’s invention of derivatives of the drug N-phenyl-2-pyrimidine-amine, one of which in a freebase — or one of the forms which many drugs can take — was called Imatinib and constituted a US patent application (no.5,521,184) granted in May 1996.  For the court, an attempt at ever-greening the Zimmermann discovery made 17 years ago, albeit with claims that newer versions are better absorbed by the human body, was, to put it mildly, unfair to patients who have paid an arm and a leg while the case dragged on.

On the access side, Novartis’s claims rested on two points. First that it was providing Gleevec free to 95 percent patients under prescription. And also, $1.7 billion worth of medicine has been doled out free under access programmes since 2002. The Supreme Court was rightly unimpressed by both of these.  The 95 percent bit is pure mathematical jugglery. It does not reflect the true base of those afflicted by the cancers in question. As for the total outgo in Novartis’s access programmes, the assumption clearly is that Gleevec costs Rs.120,000 ($2,200) a month!

Why not deflate the claim to one-fifteenth, since Rs.8,000 ($150) is all that generic folks like Cipla and Natco Pharma charge for the same compound? Beyond Novartis, the judgment is a message for the entire tribe of pharma multinational corporations: That they need to focus their research on genuine innovations than finding artful ways of evergreening what has already found protection for the prescribed period.

Finally, the judgment distills the significance of ‘context’ in statute. The concerned amendment to the Patents Act, 1970 wanted to respond to the concerns of public health practitioners across the globe over affordability of drugs — India being the leading global supplier of bulk drugs, formulations and generic anti-retrovirals. We also need to remind ourselves of the nexus between big pharma companies and their governments as brought out by a study ‘Changing Patterns of Pharmaceutical Innovation’ conducted by the National Institute of Health Care Management.

It bluntly pointed out that between 1989 and 2000, the US Food and Drug Administration approved 1,035 new drug applications. Of that, 65 percent contained active ingredients already in the market (incrementally modified drugs), 11 percent were identical and only 15 percent were considered a ‘highly innovative drug’. So, rather than creating a thicket of artful patents, and then crying wolf, the creators of similar predicament will be better off studying what US pharma major Gilead Sciences is doing in India. It is allowing Indian generic licensees to manufacture its cutting-edge medicines and letting them supply these cures to the developing world at much lower prices than the original.  Indian judiciary isn’t a group of medievalists. The courts in India, more than any one else, respect the golden compound that combines ‘access’ and ‘genuine innovation’.

Source: IANS

This novel idea was implemented by a non-governmental organization headed by lawyer Anil Kilor. He had the novel initiative of making generic drugs available to the common man. The NGO subsequently opened two generic medicine stores at Zenda Square (Dharampeth) and Yadav Nagar. The store has unique features like home delivery of medicines as well as a doctor present, who provides medical care to the underprivileged.    

Shetty said that this initiative was also to provide treatment for cancers at a subsidised rate. He said that he was hopeful of setting up a day care chemotherapy centre in the remote parts of India. A pilot project for one such centre is underway at Amravati. Shetty reassured the media, that many more such centres would be started soon. According to the Public health minister, he plans to start the first 7 such centre in Vidharba district.

On being asked about the increase in premium to avail of these services, Shetty said that the ambitious Rajeev Gandhi Jeevandayi Yojna (RGJY) will soon be launched but at no extra premium. In response Subhash Chavan (congress) raised the issue regarding the delay in implementing generic stores in Maharastra. He said that other states had set up generic stores almost 4 years ago, while Maharastra is yet to implement it. In response Fauzia Khan (minister of state for health) said that the health department has started purchasing generic drugs for all civic hospitals. She also said that the proposal for such drugs to be used was still to be approved by the state government. She said that the proposal was pending with the centre for funding aid of Rs 57.80 lakh available under a centre scheme in this regard. While the proposals are pending with the centre for funding, Khan cited this as a reason for not pushing these aggressively.

Other ministers argued that the speed with which the other states had managed to implement this system should be used as a benchmark. He also demanded the setting up of a day care chemotherapy centre. 

‘This is a landmark judgment. This will have a long-term and wide impact, as the generic version makes it more affordable for the poor. Now the prices of life-saving drugs will be reduced from Rs.1,60,000 per month to just Rs.6,000,’ Y.K. Sapru, of the Mumbai-based Cancer Patients Aid Association told IANS over phone.

The apex court Monday rejected the drug maker’s patent application for a major cancer drug, a ruling that allows cheap copies of important medicines to continue being distributed. The judgment allows firms in India to continue making copycat versions of the Novartis drug Gleevec. The drug maker argued that the drug ‘Glivec’, as it is known in India, was a newer version that qualified for a fresh patent.

Sapru, refuting apprehensions that the ruling may be seen as a violation of patent laws, said: ‘If it was a violation of patent laws, then the Supreme Court wouldn’t have given such a decision. It is in complete compliance with the rule of law.’ Sameer Kaul, senior surgical oncologist at Indraprastha Apollo Hospitals, said the decision was a step in the right direction. ‘I view this development with cautious optimism. While I am aware that we need to address the price issue of life-saving cancer drugs, we should be careful to not violate our own patent laws. The government should have stepped in much earlier to negotiate the prices with the company,’ Kaul told IANS.

‘The government should encourage the local pharmaceutical industry to spend more on research, so that we can develop own molecules. Also, the patent time-period of 20-30 years is absurd. It should not be more than two or three years,’ he said.  Professor of Oncology at AIIMS, P.K. Julka, said: ‘The ruling is good for poor patients. It will ensure continued access to cheap drugs.’

Source: IANS