Drug price order might cover devices

Proposed amendment to also state formula to decide drug prices

In sync with its agenda to make health care products affordable, the government is planning to amend the Drug Price Control Order (DPCO), 2013. The objective is to bring medical devices directly under DPCO, instead of classifying these as drugs and then subject these to price regulation, a top government official told Business Standard.
 
In the current regulatory regime, if any medical device has to be brought under price control, it must be classified as a drug.
 
The proposed amendment would also introduce a new formula for price fixation of medicines. “The government wants to make separate provisions for medical devices. However, the process is going to take some time,” the official said. The National Pharmaceutical Pricing Authority (NPPA) had earlier sought a separate provision under DPCO for devices. 
 
The move comes when multinationals, mostly US majors, are unhappy with the government for slashing cardiac stent prices by up to 85 per per cent. Recently, George Sibley, minister counselor for economic affairs, US embassy, had criticised the treating of medical devices as drugs and subjecting these to price regulation.
 
Pavan Choudary, Director General, Medical Technology Association of India, said, “It is a good thing that medical devices are getting special attention. This will help us a great deal.” But, many in the device industry were sceptical about the government’s ability to regulate prices in a rational manner. They were not willing to be quoted but said they were open to self-regulate prices.

 
NPPA has asked the department of pharmaceuticals to facilitate collection of data from insurance companies by creating provisions in the DPCO. Business Standard has reviewed the proposal.
 
At present, more than 20 medical devices have been classified as drugs and brought under DPCO but as part of the non-scheduled category. These include heart valves, orthopaedic implants and intra-ocular lenses. NPPA is now monitoring the prices of these devices. Since these are not part of Schedule 1 of DPCO, the regulator cannot fix their prices. The next step could be to bring them under price control, a source said.
 
The government is also mulling amendments to DPCO in its attempt at making medicines affordable to all. For instance, NPPA has asked the government to include Fixed Dose Combinations in the DPCO. It is seeking provision for downward revision in drug prices even when these are below the ceiling price, if the Wholesale Price Index (WPI) falls. According to current rules, if the WPI drops, firms selling drugs below the ceiling price need not slash rates.