Govt proposes to dilute National Pharmaceutical Pricing Authority’s powers
New Delhi: The government has proposed to dilute the powers of the National Pharmaceutical Pricing Authority (NPPA), the body that regulates drug prices.
The draft pharmaceutical policy, prepared by the department of pharmaceuticals under the ministry of chemicals and fertilizers, has proposed that an advisory body, members of which will include industry representatives nominated by the government, will assist the NPPA in fixing prices. And prices once fixed by the NPPA can’t be revised unless directed by the government or by courts, the draft policy proposed.
“The government will prepare the list of medicines for price regulation and transmit them to the NPPA for fixing the price ceilings. The regulator and the government would be two distinct agencies,” said the draft policy, which has been reviewed by Mint.
The NPPA shall be responsible for laying down price ceilings of selected medicines, it added.
NPPA chairman Bhupendra Singh declined to comment.
NPPA’s recent decisions to cap prices of cardiac stents and knee implants have been criticized by the industry.
The policy proposed that trade margins will be prescribed to “create a level playing field for the industry and to bring down the prices”.
D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, said that the draft policy proposals will suffocate the industry without benefiting patients.
“The key objective of the policy is to bring down the prices and provide affordable healthcare, which may not be available. The policy doesn’t talk about the promotion and growth of the industry,” Shah said.
“There are lot of statements in the policy which have no meaning. They are talking about global quality and to ensure quality, a lot of devices are needed, the cost of the companies will go up and eventually the cost of the drugs will increase,” he said.
The pharma industry, Shah said, will approach the department, other related ministries and the prime minister with their recommendations on the proposed policy. Government officials are expected to meet industry representatives on 30 September.
In a move that could start a turf war between the health ministry and the ministry of chemicals and fertilizers, under which NPPA operates, the draft policy also proposes to bring all pharma regulators under a single department.
Currently, the Central Drugs Standard Control Organisation, a regulatory body for pharmaceuticals and medical devices, is under the health ministry, while the NPPA comes under the fertilizer and chemicals ministry’s department of pharmaceuticals. “For ensuring accessibility and affordability of drugs, ease of doing business and more coordinated synergies all the regulators/commissions pertaining to pharmaceutical industries /sector will be brought within the ambit of one department,” the draft policy said.