Pharmabiz
 

A PERIOD OF INACTION

P A FrancisWednesday, January 20, 2010, 08:00 Hrs  [IST]

The Parliamentary Standing Committee on chemicals ministry in its recent review has taken serious note of the working of NPPA and the Department of Pharmaceuticals. The Committee said that the NPPA should strictly monitor the prices of the non-scheduled formulations in order to check unwarranted increase in drug prices. It should not hesitate to invoke the relevant provisions of the Drugs Prices Control Order, 1995 and fix the retail prices of non-scheduled formulations whenever required in public interest. In most price violation cases, NPPA has been detecting the offences much later on account of its inadequate machinery. Ever since DPCO 1995 was notified, pharma companies have been resorting to methods to evade price control by either altering the specified strength of ingredients in formulations or adding ingredients not listed in the controlled category of drugs. NPPA had first detected cases of violation of price control in case of tablets and capsules shortly after the notification of DPCO. That time companies have been either changing the standard sizes of strips or slightly altering the strengths of tablets to escape price control. This practice was curbed through a notification issued by NPPA on January 27, 1998 by fixing prices on a pro rata basis for strips. Recently, some new ways of circumventing price control order are being resorted to by the pharma companies. This is by way of mixing food and nutrition supplements with drug formulations. In the case of Merck India, the company had classified its leading vitamin E brand, Evion 400 tablets, into a dietary supplement just to come out of price control. The company obtained the product license with change in the composition from drug authorities of Daman. Some other products came under the government scrutiny were Revital capsule of Ranbaxy, Evion 400 capsule of E Mark, Recharge plus capsule of Trikio and multivita gold capsule of Universal Medicare. Marketing approval for dietary supplement is not granted by drug control authorities. The suggestion of the Parliamentary panel that both the Central ministries of chemicals and health should jointly work to prevent this kind of circumvention is quite significant. On pharmaceutical companies defaulting in payments of overcharged amounts, the Committee said that NPPA should act tough. NPPA has detected a total of 655 cases of overcharging and raised demands involving Rs 1,994.16 crore as on 31 March 2009. The Committee is concerned that NPPA has been able to recover only an amount of Rs 156.04 crore against the total demand of Rs 1,994.16 crore with as much as Rs 1,763.63 crore is still under litigation and locked up in various courts. The Committee has recommended that NPPA should vigorously pursue these cases and recover the dues promptly. Apart from inaction on these matters, there are a number of other policy and regulatory issues to be addressed urgently by both the chemicals and health ministries. But, the new chemicals minister is almost inactive and the health minister is extremely slow to attend to these matter ever since they took charge.

 
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