MUMBAI: A proposed amendment to the four-year-old Drug Price Control Order (DPCO) aims to bring non-scheduled drugs under price control by changing the price setting method, a move that pharmaceutical companies say will be detrimental to the industry’s growth and kill competition.Non-scheduled drugs are those that are outside the price-control regime. About 370 drugs are currently under price control.The proposal by the National Pharmaceutical Pricing Authority (NPPA) and the Department of Pharmaceuticals (DoP) suggests scrapping the current method of fixing the ceiling price of drugs on the National List of Essential Medicines (NLEM) by adopting the simple average of brands having market share of over 1 per cent and instead taking the simple average of all brands and generics.The Indian Pharmaceutical Alliance (IPA), a grouping of leading domestic drug companies, said such an amendment would “kill competition and compromise growth” and that the amendments are being discussed without carrying out an impact assessment of the current price-control policy.“Give DPCO 2013 a chance to deliver. Four years is too short a period to amend it. It has started delivering on its promise of ensuring affordability and access,” said IPA secretary general DG Shah.Shah said the faster growth in volume of NLEM products against that of the overall market also indicates rational use of medicines. “It is therefore important to undertake a formal impact analysis study before initiating amendments to the DPCO 2013,” he said.There was no response to an email sent to NPPA chairman Bhupendra Singh. A committee under DoP joint secretary Sudhanshu Pant had been asked in April to submit a report on amendments to DPCO 2013. The government wanted the committee’s recommendations vetted by NPPA and DoP. The file is currently with chemicals and fertiliser minister Ananth Kumar, said people aware of the matter.Under the existing provision, companies that launched combination or single dose drugs that might not be part of the essential list before 2013 continue to remain outside price control. Any company that wants to launch a new drug has to apply to the drug regulator, which fixes the retail price accordingly.However, under the new proposal, if a company is launching a new drug that might be a combination of a scheduled and a non-scheduled drug, the regulator will fix the ceiling price of the drug. This means that those companies that have launched similar drugs before 2013 will automatically have to follow the ceiling price.Under the draft amendment, this will be based on the price applied by the manufacturer that takes a lead in seeking approval for the new drug. Patented drugs will not fall under this formula.Shah said that this move will discourage manufacturers from launching “new drugs”, thereby reducing competition and protecting existing players.India’s $15-billion generic pharma industry has witnessed a long period of slow growth as price cuts and bans on fixed-dose combination drugs have put a halt to the double-digit expansion of a few years ago. The implementation of the goods and services tax (GST) on July 1 has further slowed growth to 3.7 per cent in the six months to September, according to research firm AWACS from 12 per cent a year earlier.“We are really concerned about this move,” said an industry executive who did not wish to be quoted.The move comes amid a broader government backed push to reduce the prices of drugs and medical devices to prevent overcharging and make them more affordable, such as the price regulator lowering the cost of stents and knee implants by more than 50 per cent .There has also been talk of asking doctors to prescribe drugs by generic name rather than brand name to disrupt any nexus between drug companies and doctors.However, some of the moves haven’t worked as intended. For instance, hospitals have reportedly increased service charges to offset the loss of margins on stents, while some companies have withdrawn their stents from the Indian market.