This article has been modified. Please see the correction at the end
While the policy is primarily aimed at making essential medicines affordable, many feel the spirit is missing in the recommendations put forward by a group of ministers a few days ago. For instance, the ministerial panel has proposed to regulate prices of only 348 essential medicines and keep combination products out of control — to the extent that even if a company manufactures a combination drug containing two formulations under price control, it still circumvents the regulation.
“In many cases, taking advantage of the escape route many manufacturers will just add a minute quantity of an irrelevant agent to convert a single-ingredient formulation into a fixed-dose combination,” says C M Gulati, editor, Monthly Index of Medical Specialities.
A representative of a leading drug maker agrees many companies would be able to bypass the norm because they mostly sell combination products.
For example, metoprolol and hydrochlorothiazide, both under the proposed price control, when combined in a fixed-dose combination, escape the price control benchmark. Many companies such as Astrazeneca and Ajanta Pharma manufacture the combination product under their respective brands, Betaloc-H and Met-XL-H, trade sources say. Similarly, Cipla’s popular anti-hypertension medicine Amlopres-AT and Intas Pharma’s Amtas-AT would bypass price control even as they contain amlodipine and atenolol, both of which are part of the 348 essential drug list.
“Around 40 per cent of the total drugs sold in the country are fixed-dose combinations and they are not under price control. So, the whole purpose of the policy is defeated,” says Gulati.
According to Amit Sengupta, the co-convenor of Jan Swasthya Abhiyan, a public health advocacy movement, such a loophole would not only result in companies migrating out of price control but have a larger implication on public health. “If the government does not bring combinations into price control, it will promote the proliferation of irrational combinations, which would be a bigger problem,” Sengupta said.
Besides, the panel has recommended price control only on the basic formulations in any particular therapeutic area and left out various equivalent alternatives used to treat the same diseases. That would enable companies to escape price control by switching over to producing alternatives not part of the regulation. For instance, enalapril, used to treat high blood pressure and under proposed price control, is currently being sold by drug makers such as Dr Reddy's and Cadila Pharma. However, as soon as the policy comes into effect, these companies may start manufacturing alternatives such as fosinopril, imidapril, lisinopril, perindopril, quinapril, ramipril and trandolapril, which are all equivalents of enalapril. Similarly, the anti-epileptic carbamazepine can be replaced by oxcarbazepine, whereas painkiller diclofenac can be replaced with aceclofenac. Currently, companies like Novartis, Dr Reddy’s Labs, Cadila and Ranbaxy manufacture some of these drugs that may come under price control.
“This is a major loophole in the proposal. A class of drugs has got various molecules and you are bringing only one under price control. Of these 348 medicines, there is hardly any drug that does not have an alternative or rather a superior one,” says Gulati.
The panel, headed by Sharad Pawar, finalised its recommendations on the proposed National Pharmaceutical Pricing Policy on Thursday. It will send its suggestions to the Cabinet in a week’s time, Pawar has said. Various health groups have opposed the proposed formula.
Correction
This article had wrongly mentioned enalapril as ethromycin, which has been corrected. It was also mentioned that Pfizer, Alembic and Ipca Labs sell the product which was wrong. Dr Reddy's and Cadila sell the medicine.
