K J Yesudas files writ petition in Kerala High Court to make life-saving drugs affordable for poor

An Indian court has asked the government to intervene and control the prices of life-saving drugs sold in the country acting on a petition filed by a veteran playback singer.

The High Court of Kerala, a southern state of India, has ordered issuance of notices to the Centre and the State Government on a petition filed by singer K J Yesudas seeking a direction to the state government to intervene and control the prices of life-saving drugs, reports said.

K J Yesudas is well-known play-back singer from Kerala.

In his petition, Yesudas pointed out that the prices of life-saving drugs have gone out of the reach of the poor and the downtrodden as their prices went extremely high in the recent years. People, especially those in the lower-income sections of the society, who deserve to get it free if not at a subsidised rate, is finding it difficult procure the life-saving medicines because of their prohibitive costs.

Yesudas moved the High Court seeking the intervention of the court to give directions to the government to exempt the life-saving medicines like anti-cancer drugs from various taxes and import duties as suggested in the National pharmaceutical policy, and make them affordable to the poorer sections of the society.

Yesudas’ writ petition also sought a declaration that the Central and State governments had a constitutional duty to provide anti-cancer and other life-saving drugs to patients under the poverty line free of cost.

Yesudas sought a direction to implement the Provisions of National Pharmaceutical Policy and Health Policy.

Currently, there is no no mechanism in place to fix and regulate the prices of medicines, especially anti-cancer drugs and life-saving drugs. The government has provided are no guidelines or criteria for fixing the maximum retail price of life saving anti-cancer drugs, the petition alleged.

A Division Bench comprising Chief Justice S R Bannurmath and Justice Thottathil B Radhakrishnan accepted the petition on file and issued notices to the the Central government and the Drugs Controller-General of India as well as state government, reports said.

India, which is used to a generic-driven market for such a long time finds most of the new generation drugs as too costly for the commoner. Some of the cancer new generation cancer drugs costs hundred to three hundred times the price of the similar therapies available in the Indian market.

Pfizer, for example, which was granted a patent for its kidney cancer drug Sutent (sunitinib) in India in 2007, launched the drug at a price of Rs 1.96 lakh for a 45-day treatment in the country.

Roche’s Tarceva is another case in point. Tarceva (erlotinib) is a novel therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva costs around Rs 3,30,000 for a 3-month treatment.

Recently, Surinder Singh, the Drug Controller General of India (DCGI) had recommended that cancer drugs be brought under the National Pharmaceutical Pricing Authority (NPPA).

“As the DCGI, I have outlined the technical inputs and rationale behind the suggestion for the inclusion of new drugs. Cancer drugs, in particular, should be included, since they are expensive and beyond the means of the common man,” Mr Singh was quoted as saying.

Even though the DCGI has mooted the proposal, a final decision on this was to be taken by the department of pharmaceuticals.

Cancer and HIV drug marketers in India includes both the multinational companies as well as the domestic companies who are having a cancer drug franchise.

Of late, several MNCs have been identified India as one of the emerging market to sell their top selling drugs.

Roche, GSK, Novartis, Merck, Pfizer, Eli Lilly, Sanofi-Aventis etc have already launched their new generation cancer drugs in India eyeing India’s fast growing oncology (cancer) segment.

Cancer accounts for 3.6% of the total deaths in India, the second-largest non-communicable disease. Oral and lung cancer in males and cervix and breast cancer in women account for over half of all cancer deaths in India. Market for breast cancer drugs alone is expected to double from $35 million in 2007 to $64 million by 2012.

Indian drug makers also have several oncology drugs marketed in India. Dabur, Dr Reddy’s, Cipla, Natco are some of the prominent players in the oncology segment.

In June,the Union Finance Ministry is urged to cut down duties on cancer/AIDS medicines in forthcoming budget.

A proposal to cut down the excise and customs duties levied on cancer and HIV drugs across the board has been mooted by the Department of Pharmaceuticals as part of its pre-budget recommendation made to the Union Finance Ministry to make drugs in critical segments affordable the common man.

The Department of Pharmaceuticals was set up in 2008 under the Ministry of Chemicals and Fertilizers to oversee and promote the pharmaceutical industry in India.

It has been reported that the Centre might hike customs and excise duties on certain drugs in the forthcoming budget.

Excise duties of certain drugs used in critical segments like cancer is already cut down to zero or four percent.

The Union Government brought down the excise duties on medicines in the previous year’s budget to 8 percent from 16 per cent. In December, the Union Government slashed the excise duty again to 4 per cent.

The Department of Pharmaceuticals has reportedly sought the Finance ministry to continue the duty at  4 per cent for the finished drug formulations.

The dept has also  recommended an increase in the rate of abatement on the MRP-based excise to 60 per cent.

The finance ministry is also sought a weighted deduction on research be extended from 2010 to 2017, the official said. At present drug companies get 125 per cent weighted deduction on research outsourced to a third party and 150 per cent on in-house research, reports said.