India’s meek submission to MNCs

Central government is capitulating to demands of pharma MNCs and denying Compulsory Licence to Indian firms to produce generic versions, which are far cheaper than patent products. Even foreign governments are putting pressure on India so as to protect the interests of their companies. Meanwhile, some Indian companies are going in for co-marketing of patent medicines, thus erasing any scope for new generic medicines in the future. Not only Indian masses, a large number of nations depend on affordable generic versions made by Indian companies. Centre’s caving in to the MNCs is dashing their hopes

Medicine marketed with its chemical name without any brand name is, actually, called a generic medicine. But the term now is generally used to refer to all brands of a same molecule and in due course they have acquired the name ‘branded generics.’ As the patented medicines are too costly, the same molecules being promoted under various provisions available in countries abroad are now referred to as generics.

Besides antibiotics, cardio vascular, diabetic and other medicines meant for various indications, Indian pharma companies are supplying anti retrovirus medicines meant for treating HIV positive and AIDS patients in Africa and many other countries.

Around 80% of such medicines used in Africa and undeveloped countries are supplied by the Indian companies and the cost difference between such medicines and the patented brands are unimaginable. India is, thus, rightly called ‘the Pharma Hub of the World.’ The sales of such medicines done by the Indian companies have reached an enviable level.

Such sales in 2015 alone were to the tune of $12.54 billion and have the potential of doubling in just five years. But such sale with phenomenal growth has its heavy toll on the sale and profit of the patented molecules and has, naturally, drawn the serious attention of the patent holders.

To counter such surge in the sales of generic version of their patented molecules, all-out attempts are being made by the pharma MNCs. Even mischievous propagandas are made on our medicines as ‘spurious’ and ‘substandard’ ones. The quality specifications laid down by the FDA of US are insisted on, to be adhered to by our manufacturers, though we have our own strict standard specifications in vogue.

There are around 60 manufacturing units in India which are monitored by the USFDA. FDA has even set up its office in India to carry on such monitoring. Agreeing to such intrusions and monitoring speaks volumes of our succumbing mood and, no doubt, it is a shame for us, besides the fact that accepting such conditions is otherwise substantiating the spurious claims of MNCs about the quality of our medicines.

To make such useful molecules available in our country under Sec 84.7(a) iv of the Indian Patent Act, the government holds the right to issue Compulsory Licence to Indian manufacturers to produce and market any patented molecule. The Act says Compulsory Licence can be issued, “if the development of commercial activity in India is prejudiced.”

The government invoked such a provision and gave Licence to Natco Pharmaceuticals, an Indian company based in Hyderabad, to produce the same molecule of Bayer (Nexavur), a medicine used to treat liver and kidney cancer. As against the cost of the patented molecule at around Rs 3,30,000 per course, the Indian brand is available at the cost of around just Rs 8,800.

Though highly beneficial, in India this provision is invoked only once, whereas countries like Zambia, Zimbabwe, Ghana and Mozambique have utilised this provision a number of times. In spite of the fact that we have not been issuing Compulsory Licences lavishly, enormous pressure is being exerted on the Indian government by the governments of the developed nations to do away with such a provision.

Application seeking Compulsory Licence provision to manufacture Saxagliptin, a medicine used by diabetic patients that costs around Rs 52 per tablet, has been declined by the Indian government. There are many patented medicines, a few are mentioned in the table, which are costlier and are still not considered for issuing Compulsory Licence.

It is needless to say that the prices are exorbitantly high and not all Indian patients can afford. Therefore, there is a need to consider granting Compulsory Licence under the provisions of the Act. But to avoid this, the Indian government is blackmailed and coerced to keep Indian pharma companies in watch list, which is otherwise a threat to blacklist our firms.

It is unfortunate that our government is succumbing to such pressures from the governments of the developed nations. Mukesh Aghi, the President of US-India Business Council certified: “India has denied several CL applications.” It is also revealed in the US Congress that, “Govt of India has reassured not to use CL for commercial purpose.” Such crucial decisions should be taken only after taking our parliament into confidence.

But underground dealings on such vital issues will lead to a chaotic situation in the long run and ruins the domestic pharmaceutical industry, besides spelling its telling negative effect on the ailing masses of this country.
It is also observed that many patent holders are going all-out to nullify the relevant sections of the Indian Patent Act that denies them permission to get their patent right extended by a few insignificant changes in the molecule.

Novartis made futile attempts to get permission for its product Imitab to enjoy ever green patent right in a clandestine manner. Now, the government is under pressure and it has also formed a committee to study the intellectual properties right and suggest changes accordingly to address the grievances of patent right holders, which signals the government’s succumbing mood.

Many European pharma companies are also exerting pressure through EU and Trans Pacific Project agreement to insist that India accept DATA Exclusivity. Along with application for patent right, the data of the molecule’s clinical trial reports are also submitted to substantiate their claim on the safety margin of the product.

At present, one such data is enough and not all those who apply for the same molecule need to submit separate data. Now, the government is pressurised not to disclose to others the data presented by MNCs and are demanding exclusive rights on their data for 5 to 10 years.

If accepted, all the applicants should be compelled to provide their own data, which means every applicant should hold extensive trials on every aspect of the molecule, which involves huge expenditure and time, besides concerns on ethical ground.

It is a matter of concern that even newly registered non-patented products are included in their list. It is believed that such demand is agreed to be considered much against the benefits to the domestic players. Such bilateral and multilateral agreements or understandings entered into by the government are sure to spell doom on the future of our shining Indian pharma industry.

The Indian pharma companies, which were putting up some resistance for some times, are now found to be reconciling to the yielding mood of the Indian government and are searching for ways to sail along with the MNCs even in the adverse situation. Some of the giant Indian pharma companies are entering into contract with patent right holders for co-marketing or obtaining marketing rights by paying royalty.

Already we find Dr Reddy’s Lab co-promoting Riox (Saxagliptin), a molecule of Astra, meant to be used in diabetes management. Astra, an MNC, has already given away many of its patency expired products to some Indian companies and is concentrating promoting its products with live patency. In the process, thousands of sales promotion employees are stripped of their employment, which will impact the manufacturing units also.

It is time the government stopped succumbing and started looking into this serious issue with all its sympathy for the ailing masses, rather than become over enthusiastic in offering extraordinary profits to the multinational pharma companies.

By: A G Rajmohan