Taking advantage of poor knowledge of consumers, malpractices by doctors and weak regulation, drug companies are selling medicines at hugely inflated prices. What is the government doing to combat this menace? This is the second part of an exclusive Moneylife investigative series

The Drugs Price Control Order (DPCO) of 1995, issued under Section 3 of the Essential Commodities Act, 1955, was meant to regulate drug prices. The National Pharmaceutical Pricing Authority (NPPA) was set up in 1997 and vested with the powers to implement the DPCO but with little impact. The NPPA is an autonomous and independent body of experts that monitors, fixes and revises drug prices. It is attached to the ministry of chemicals and fertilisers and is hobbled by the requirement of having to refer all actions to the ministry before issuing orders.

Dr Chandra M Gulhati, editor, Monthly Index of Medical Specialities told Moneylife, "The objective of the drug price regulation is to help people to get quality drugs at affordable prices. Over the years, the number of drugs under price control has steadily decreased from 347 (in 1979), to 142 (in 1987), to 76 (in 1995); now it is just 74. Of these 74, the 24 molecules currently under DPCO (such as captopril, chlorpromazine, phenylbutazone, etc) are outdated and superseded by newer molecules which are naturally outside the price control.

Of these 74, only 63 drugs have been notified. Hence, 11 drugs have no ceiling prices. And, the number would have dropped to 34 under the Pharmaceutical Policy 2002 but for a legal stay granted by the Karnataka High Court. This corresponds to less than 5% of all major molecules in India." 

Clearly, there is an urgent need to make NPPA effective and enlarge the list of price-controlled drugs to at least cover the National List of Essential Medicines (NLEM), which has 354 drugs and covers a market size of Rs7,000 crore. Based on demands from NGOs and social organisations, the health ministry has mooted a proposal to amend the NLEM to cover cancer drugs. These are mostly manufactured and sold by multinationals such as Novartis, Roche and GSK and can cost up to Rs1.25 lakh for a month's treatment.

Branded, Generics and Branded-Generics

What exactly do these mean?

In India, branded medicines contain one or more ingredients marketed under brand names given to them by their manufacturers. It allows doctors to promote the brands and it is an open secret that many receive a kickback from manufacturers for doing so. In Western countries, it refers to new drugs developed by the innovator patent-holding companies. (After India signed the WTO agreement, all medicines patented after January 2005 are monopoly products of manufacturers and are sold under brand names).

Generics are medicines sold under their chemical names. In Western countries, it refers to medicines whose patents have expired and can be produced by anyone under new brand names. The term 'Branded-generics' is an Indian coinage that refers to branded products that are marketed through heavy incentives to retail chemists (not promoted by doctors). Obviously, such products are unethically and illegally sold either without prescription or by substituting prescribed brands. This is a well-kept secret. Moneylife discovered, quite by chance, that whenever you ask for a product by a generic name (we asked for vitamin E and erythromycin in two separate cases, with two different pharmacies at different times), many pharmacies immediately offer you the product of an unknown company at a hugely inflated price. Naturally, they don't bother with a prescription or a bill. In both cases, the packaging and the colour were very similar to those of the market leaders such as Pfizer's Erythrocin 250 and Merck's Evion 400 for vitamin E.
 

Companies manufacturing drugs that are not in the price control list can raise prices by 10% annually. If the rise is more than 10%, the NPPA requests them to reduce prices, says NPPA chairman Mr Jharwal. Dr Gulhati says, "NPPA's power to monitor and control prices needs to be vigorously used." He also says that the base price which is the starting point for subsequent hikes, also needs to be reviewed to "prevent acute, recurrent and chronic profiteering" and "in no case should the MRP exceed the current retail price of an existing equivalent brand for setting the base price of a new brand in the decontrolled category. Otherwise companies will launch products at a high price and still claim an annual hike of 10%."

In any case, companies continued to violate the 10% ceiling on price hikes too. We found that 22 brands in the non-controlled categories had hiked prices by 20% in 2007. They reduced the prices after an NPPA order. There has been continuation of stray violations in later years. NPPA needs to be better empowered. For instance, if a multi-ingredient formulation with one price-controlled molecule is launched, it should be mandatory to seek NPPA approval for pricing. Otherwise, action is initiated only when NPPA notices over-charging. Even here, it cannot take drastic action. It can only issue notices to seek reimbursement of the excess charged. This ends up in a legal battle and does not help the customer.

(In the next article in this series, we look at the rumblings in Parliament over the exorbitant pricing of drugs, and the recommendations of the Standing Committee)