Though the new Drug Price Control Order (DPCO), 2013 is ready for notification any time, the delay in the hearing of the pending case in the Supreme Court has caused uncertainty over the much-awaited pharmaceutical pricing policy.
The DPCO, which will frame a mechanism for pricing of essential drugs in line with the policy, is currently being vetted by the Law Ministry and will be notified for implementation any time. The Department of Pharmaceuticals (DoP) had already cleared it after the minister for chemicals and fertilizers signed it sometime back, sources said.
However, the case on the policy is still pending in the Supreme Court which has to deliver its final judgement. Though case was supposed to come up for hearing on January 15, it did not materialize due to the paucity of time.
“We are also waiting for a date for the hearing now. No date has been fixed yet,” a spokesperson of All India Drugs Action Network (AIDAN) said. AIDAN had filed the public interest litigation in 2003, prompting the Apex Court to interfere in the case and taking the matter to this stage.
According to the some public interest groups involved, the pricing of patented drugs was not included in the policy and in between the DoP has come out with a formula to negotiate the pricing of patented drugs. But no final decision is yet to be taken on this. This could also further delay the case in the court, a leader pointed out.
Meanwhile, the new DPCO will practically put the new pricing policy in effect once it is notified. The Government will give a window period for the industry to implement the Order that was revised in line with the new policy which will cover 348 essential medicines under price control.
The new DPCO will replace the existing DPCO, 1995. It will lay standard norms and procedures to be followed by the industry as well as the regulator for fixing and monitoring prices of medicines in the country.
According to reports, the new DPCO has overhauled the existing norms. The firms have to issue a public notice and inform authorities six months in advance if they planned to stop production of any formulation of essential drugs, as per the new DPCO. The Government will also have the right to direct the companies to continue to produce the required level of essential drugs in public interest. The drug makers will have to maintain records relating to the sales of APIs (active pharmaceutical ingredients) and bulk drugs, manufactured or imported.