Drug manufacturers seek privacy

New Delhi: It is not just fuel and food items, even medicines could get costlier. These include several life-saving drugs.

What goes into the making of these life-saving drugs? It is only the companies who manufacture them know.

During clinical trials, before introducing the drugs in India, they document them and submit this data to the Drug Regulatory Authority (DRA).

Now, the patent holders are asking the government to introduce a data exclusivity clause. This means DRA will have the data but cannot use it.

And the local manufacturers will have to conduct their own trials to get substantial information on the drug safety and efficacy. The fear is that it could mean higher prices as well as delayed availability

"Patients are very dependant upon the drugs produced by the Indian generic industry. So, not only patients in india, but alos patients in other developing countries will have to wait for three to five years before they can access newer drugs," says Project Manger of Medicine at San Frontiers, Leena Meghaney.

According to the World Health Organisation, there is no requirement under the international law for countries to give data exclusivity to patent holders.

But the Indian government is now on the verge of amending the Drug and Cosmetic Act to include this clause.

"Data exclusivity is in itself a misleading term. It conveys the meaning that there is an exclusive right on the data, but in practice or on the ground, it works as a market exclusivity, similar to patent monopoly," says K M Gopakumar, intellectual property right lawyer

CNN-IBN has documents that show that initially Health, Commerce and Chemical and Fertilizer Ministries were all against data exclusivity.

But now, the government has shifted its stand after the Department of Scientific and Industrial Research recommended that generic versions should be allowed only after three years.

The Chemical and Fertiliser Minister, however, still talks about a people-friendly patent regime.

"We are going to put our policy in front of the Cabinet. Our only mission is to function in the interest of the public," says Union Minister for Chemical and Fertiliser, Ram Vilas Paswan.

Data exclusivity will clearly have 2 fallouts - a delayed availabilty of medicines and an unneccssary human testing.

But what remains to be seen is whether the government makes an intelligent choice or rather which is of a greater priority for the goverment - public health or the commercial interest.

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