NPPA attacks Pharmaceutical Industries

On 17^th, May National Pharmaceutical Pricing Authority (NPPA) issued a notice against many pharmaceutical companies like Lupin, Zydus Cadila, Wockhardt, Abbott Healthcare, Alembic, Alkem, Zuventus Healthcare, Ranbaxy, Sanofi India, GlaxoSmithKline, who are selling hundreds of fixed doses combination (FDC) drugs without conforming with NPPA. FDC is a combination of two and more drugs, and is considered as new drug. NPPA observed that the pharmaceutical companies in India are breaching the estimated price cap without its consent. NPPA enlisted 201 drugs that tried to violate the price control, fixed-dose combinations (FDCs).

The pharma pricing controller has solicited the firms to furnish details of batch-wise production and sales, with maximum retail price (MRP). In the notice, the state drug regulators have been requested to monitor unapproved medicines being sold in the market. NPPA also declared that if they do not receive suitable response, they will continue to act according to the Drug Price Control Order,2013 and Essential Commodities Act, 1955. The NPPA would also cater to the uncertainty about the formulations of drugs that agree with the Central Drugs Standard Control Organization (CDSCO) and whether these are rational or irrational drugs, as many of them are FDCs.

NPPA role to control price on medicine

NPPA demanded the pharma industry to caution their members to attain prior consent of prices from the office before launching any formulation that may be categorised as 'new drug'.

As per DPCO, if the existing manufacturer neglects or fails to apply for the approval of the price of the new medicines, the manufacturer will be subjected to charges over the price fixed by the NPPA, along with an interest. Drug pricing regulators of India are also planning to coordinate with state governments across the country to combat cheating by drug makers. Lack of data has been a main handicap at the NPPA, with the regulator looking to plug the loophole with better coordination with state governments. The NPPA is also working at collaborating closely with state drug regulatory agencies. In 2016, the NPPA has been trying to recover $678.88 million, along with the interest, from various pharmaceutical companies for overcharging customers. 

Assessment

NPPA needs to dispose all the medicines, which includes irrational combinations in the market that includes practically zero or therapeutic value and a large group of unsafe medicines. The NPPA should also check on the companies as to whether they have introduced an alternative medicine for any medicine. For instance, Paracetamol must be sold as Paracetamol and not Crocin or Calpol. The NPPA should publish the price of all the drugs through newspapers or pamphlets so that the consumers have the access to the actual price of the medicine and are not cheated by the Companies. They should have more transparency in their regulatory system as to reduce production of alternative medicines at different prices.