Generics: A promising era in Medicine

Arun Bharati, an 18-year-old from Bihar was diagnosed with Hodgkin’s lymphoma, a cancer that affects the lymphs, at All India Institute of medical sciences (AIMS) in New Delhi earlier this year. On learning that the drugs would cost him Rs 300000 per month, his dad, who was a farm labourer, committed suicide as he couldn’t afford the mammoth amount.

Arun’s tragic story speaks of millions others who, unable to afford the drug rates, opted to end their lives themselves than wait for the disease to nibble on them.

While the poor give up their hopes on getting a quality treatment, the middle class end up selling all their possessions, and drowning themselves in bankruptcy by the time they accumulate enough for the treatment.

And this is a phenomenon which is prevalent worldwide, not just in India. High drug prices are responsible for the deaths of more than one lakh people in the US, who cannot adhere to the costly medical prescriptions.

It is quite unfortunate how lives are lost in spite of having the medical facilities and technology to treat the diseases. Nothing could be more tragic than having the life saving technology in front of you and not be able to use it. This would almost measure to a cruel manslaughter.

So why is the system so skewed?

The answer is – Monopoly.

The way the drug companies operate today is almost like a monarchy where they decide the price and distribution of their medicines. The fulcrum of the weighing balance is in their hands. They can incline it to any side so as to stabilise the profits of their company by increasing the prices of drugs.

The pharma companies work with a sense of complete, almost possessive ownership of their product. This explains the concept of branding, wherein the same drug made by three different companies can have three different brand names and be sold at three different prices.

So how do the patients decide what to buy?

Unfortunately the patients make just pseudo consumers to the drugs. The real ones are the doctors who are made to strike a deal with different pharmaceutical companies via a medical representative who in turn gives a tempting commission to the doctor for endorsing the company he represents. The patients are left with no other option, but to buy the medicines prescribed by the doctor. Isn’t that a clever vicious cycle?

Dr C M Ghulati, Editor of Monthly index of Medical Specialities says that today in India, a pharma company spends nearly Rs 1,31,000 on one doctor per year. The whole money mongering industry of doctors and pharma companies to market the medicines amounts to Rs 1,2000 crores per year.

While it is a win-win situation for the doctors and the Pharma companies, the patients are left in a drain of manipulation, bankruptcy and suicides.

However, the world isn’t deprived of all hopes yet.

The industry of generic medicines has brought in a new ray of hope for those who thought drugs were a luxury.

The AIDS drugs was priced at $10,000 per person until 2001 when the Indian generic drug giant, Cipla started selling the drugs at a much cheaper rate of $150 per person.

The concept of generic medicines, which is gripping the market at present, requires all pharmaceutical companies to register for market license in the generic name and not the brand name.

Crocin, instead of its brand name will now be sold as paracetamol at much cheaper rate.

As far as India is concerned, the generic drug revolution had started in 1972 when a law was passed that could enable the emulation of any drug, even if under patent, unless the process isn’t the same. This gave Cipla the opportunity to make low cost drugs for the poor.

However, in 2005 India signed the Trade Related Intellectual Property agreement which was a major setback for a country with such a huge population. The agreement required the companies to keep the patent on new drugs for 20 years.

This gave the right manure for a monopolised structure. Though licensing was given by the government to few generic companies to copy the drug before the end of the patent period in case of public interest, it was a cumbersome process to get license from each company.

There has been a perennial argument between the Pharma giants and the poor sections of the society on the issue of patents.

While the companies insist on getting patents on the newly developed drugs as it would help in protecting the intellectual rights and also motivate in the development of new drugs in the country, the poor argue that if the patents are given the high prices would literally kill them.

The recent conflict between the pharma giant Novartis and the Indian Government over the drug, glivec is an accurate example of these arguments.

While the Generic medicines ensure the affordability of medicines to the weaker sections, the Medicines for Malaria Venture(MMV), a non-profit organisation, has taken an initiative to openly share the drug development data for the patients word wide through an open access portal called Malaria Box, a platform where any new research in the field can be shared by anyone.

India has now put a $5.4 billion policy to provide free medicines which is to be fully operational by 2014 for which sates would be providing 25% of the cost and the rest will be provided by the Central Government. The policy is aimed at covering 52% of the population by 2017 at a cumulative cost of 300 billion rupees.

Under this policy, the doctors are only supposed to prescribe generic drugs. They could land themselves in punishment if found prescribing the branded ones.

Generic makers, Dr Reddy’s and Cipla will be benefited whereas the global drug makers, Pfizer, GlaxosmithKline and Merck will be hit the most.

Earlier this year, Cipla cut prices of key cancer drugs by nearly 75%. Kidney cancer drug, Sorafenib, which was sold under brand name Nexavare by Bayer, will now be available at 6,840 per month, down from 28,000 per month. Similarly, Lung cancer drug Gestinib, which was sold by AstraZeneca as Iressa for Rs 10,000 will now be made available at Rs 4,250.

However, it is necessary to check the quality and efficacy of drugs produced by the generic industry. There is always the problem of having hundreds of generic versions of one drug. It is necessary to regulate the generics of a particular compound and ensure quality and bioequivalence to its pioneer drug.

Unfortunately, Central drugs Standard Control Organisation; the drug regulatory body in India, is understaffed and also lacks sufficient labs to check the quality of medicines. While this is an issue which needs to be tackled, other challenges would be the lack of awareness about generic drugs among the patients and a lack of doctors’ buy in.