The government today filed a special leave petition in the Supreme Court against the Karnataka High Court order that stayed the operation of the Pharmaceutical Policy, 2002, and the announcement of the Drug (Prices Control) Order, 2002.
The stay on the pharmaceutical policy has not only stayed all the development activities in the pharmaceutical sector but is also affecting the public interest at large because the Karnataka High Courts direction keeps certain manufacturers of essential drugs out of the purview of the price control mechanism, the petition states.
The petition also raises several questions of the law. Can courts exercise writ jurisdiction and decide on questions of implementation and non-implementation of policy matters?
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Can courts examine merits and demerits of a policy decision? Whether a petition questioning the proclaimed policy of the government can be entertained by the high court?
A particular drug becomes life saving in a particular situation, the petition states.
For instance, in a case of severe dehydration, oral rehydration solution (ORS), a simple mixture of salt and sugar, becomes a life-saving formulation.
Moreover, the country is mainly dependent on the import of many life-saving drugs and there is no control on their import prices.
An exercise to control their prices will hit their import and thereby availability, government officials say.
Also, the overall consumption of these drugs is small compared with the basket of essential and other drugs referred to in the policy.
The objective of the policy is to benefit a large number of consumers, which is why the criterion of mass consumption has been laid down, they add.
The proposed policy change would reduce the number of drugs under price control to around 30-35 from 74.
The Karnataka High Court in an interim order on May 30, 2002 had directed for maintenance of status quo with regard to the operation of the Drug (Prices Control) Order, 1995.
The court passed the order in a public interest litigation seeking withdrawal, revocation and cancellation of the Pharmaceutical Policy, 2002 and status quo with regard to the operation of the Drugs (Price Control) Order, 1995.
The government then filed an application before it for the vacation of the interim order.
The court later vide the impugned order dated August 9, 2002 slightly modified its earlier order dated May 30.