Draft pharma policy: NPPA raises concerns over plan to dilute its powers

New Delhi, Sept 2017:

India's drug pricing regulator has raised concerns over the draft pharmaceutical policy that proposes to dilute and crimp its powers by converting it into a multi-member body.

"Don't dilute it in the name of strengthening," the National Pharmaceutical Pricing Authority (NPPA) tweeted on Wednesday night, after the department of pharmaceuticals suggested appointing a government-nominated "advisory body" on pricing.

The department suggested that NPPA be assisted for pricing by the advisory body with doctors, pharmacists, civil society representatives, industry representatives and government representatives as its members.

But the NPPA in a series of tweets opposed the proposals. "Create appellate tribunal for appeal against NPPA orders," it tweeted, hinting at a statutory status being given to NPPA. In its draft policy, the pharma department had suggested "the appeal against the decisions of Authority shall lie with the government and against the decisions of the government, with the higher judiciary".

While stakeholders have to share their suggestions by Monday with the department of pharmaceuticals, NPPA was quick to tweet out. "Drugs are not commodities, statutory status to NPPA under the new affordable healthcare Act, abandon EC Act (Essential Commodities Act)," it tweeted, hours after a meeting on Wednesday.

The department of pharmaceuticals on Wednesday held consultations on the draft policy with stakeholders, which was attended by representatives from the pharmaceutical industry, including the Indian Pharmaceutical Alliance (IPA) and the Indian Drugs Manufacturers' Association (IDMA), as well as officials from the NPPA, the ministry of health and family welfare and the ministry of commerce.

Other proposed changes by the pharma department include conferring absolute powers to itself for vetting the National List of Essential Medicines (NLEM) and deciding which drugs should be excluded from price control; bringing all strengths and dosages of specified drugs under price control; doing away with the "retail price" and having only the "ceiling price" for non-scheduled products, thereby expanding its span of control.

The NPPA tweeted, "do not erode the extraordinary powers".

"Pricing policy should be flexible containing all good aspects of other policies," said another tweet, further recommending its "greater say in the NLEM".

According to the draft policy, "the government in the DoP (department of pharmaceuticals) will prepare the list of medicines for price regulation and transmit them to the NPPA for fixing the price ceilings. The government shall not be the regulator and the regulator shall not be the government."

The draft policy has not gone down well with industry either, with the IPA, asking the draft be "held in abeyance". "The outcomes of this policy will be neither in the interest of the patients nor in the interest of the industry," said IPA secretary general D.G. Shah.

IDMA secretary general Daara B. Patel said, "They are two things that we want to share with the government that we must continue with loan licensing and the change in their proposal of P2P. We are saying that if one man is making different brands of the same molecule, it should be put at same price but if it is a contract manufacture and making it for many companies that the price can differ."