The Pharmaceutical Policy 2002 when announced in February 2002 raised a lot of expectations in the country's drug industry. The policy draft had laid down a framework for the growth of this industry in post-2005 era. The main focus of the policy draft was to reduce the span of price control. The proposed reduction in price control on drugs was in consideration of two factors. Firstly it was in line with the government's overall policy of liberalization of industrial sector. Secondly, prices of several controlled bulk drugs have declined over the years due to imports and lower costs of production making them irrelevant to be under price control. Thus, only formulations of around 30 drugs were sought to remain under price control as against 74 under the DPCO, 1995. The approach of the government to reduce the span of price control in the new policy was acceptable to all sections of the industry although inclusion and exclusion of certain drugs were being debated. However, the policy draft was cleared by the Cabinet in February itself and the new DPCO should have been notified at least by May, 2002. But, this did not happen for some strange reasons and then came the stay order from the Bangalore High Court challenging Pharmaceutical Policy and notification of the new DPCO. The petitioner, an NGO, questioned the very intention of government lifting price control on several drugs in the new policy.
The NGO moved court as it felt that new policy will release several essential drugs from price control leading to a flare up in drug prices. The matter is now in the Supreme Court after the department of chemicals and petrochemicals went for an appeal against Karnataka HC. The stand of the NGO cannot be ignored totally considering the number of violations and circumventions of price control order usually take place in this critical industry. Apart from this, there has been a steady increase in the number of approvals of new drugs and fixed dose combinations by the office of DCGI. The latest figures show that DCGI had cleared 88 new drugs and 40 fixed dose combinations since January 2002. And most of these new drugs may not figure in the new price control order as per the parameters of new policy document. These new drugs and combinations are already in the market and are being sold at very high prices. It is possible that all of them may not be life saving drugs but certainly some of the anti cancer drugs, lipid lowering agents, anti bacterials, etc. have to be considered for price control. Now after 2 years of announcement of the new policy, there is no indication when a judgement is expected from the apex court as no parties are seeking a date for final hearing. Even if the Supreme Court comes out with an order favouring the government, the Pharmaceutical Policy 2002 stands outdated. A drastic revision of the policy draft is what is required incorporating latest figures of all new drugs introduced in the market since 2002.