The Hindu Business Line : No directions yet on biogenerics

Biogenerics is a grey area even in the international arena, industry analysts said. The expert committee probing the issue was expected to give some direction to the issue even as the country prepares to market more biogenerics in the country.

New Delhi , Oct. 5

THE much-awaited expert committee report on the biotech cancer drug filgrastim has been submitted to the Drug Controller-General of India (DCGI) close to two years after the issue rocked the pharma industry with drug majors Nicholas Piramal India Ltd (NPIL) and Dr Reddy's Laboratories (DRL) locking horns over the issue.

But the final report recently submitted by the expert committee has far from given any direction to the issue of biotechnology drugs and their generic or copy-cat versions.

The report has in its recommendations said that Grastim, the biogeneric drug from DRL that came under the scanner, was identical to Neupogen, the trademark name for filgrastim originally manufactured by Roche. Neupogen has been licensed in India to NPIL and the company markets the product under the same name.

However, DRL has been debarred from using the name Grastim on its product, as per a World Health Organisation - International Non-proprietary Name (INN) committee's recommendation that in the choice of a brandname, the stem of the generic name should not be used.

Industry representatives point out that the DCGI had in fact directed DRL to refrain from using the word filgrastim in October 2001 and, hence, this was hardly a material finding.

Biogenerics is a grey area even in the international arena, industry analysts told Business Line and the report from the expert committee, headed by the Indian Council of Medical Research (ICMR) Director-General, Prof N.K. Ganguly, was expected to give some direction to the issue in India — even as the country prepares to market more biogenerics in the country. In fact, Chinese and Argentinian filgrastim are already said to be at the DCGI's doorstep awaiting clearance, industry representatives said.

NPIL had clashed with DRL on Grastim, raising questions on the drug's safety and efficacy, given that DRL had changed its product inserts (PI) several times, where it even dropped claims of paediatric use, among others. Product inserts give the consumer/doctors details on a drug, its impact and conditions for use. However, DRL had claimed that NPIL's grouse was the price factor, given that Grastim was priced lower than Neupogen.

But pharma industry sources point out that while in the case of allopathic or chemical drugs, a copy-cat version can be imported into the country provided it had an established safety profile in markets abroad, the case was not so with biotech drugs. "There is no last word yet on issues of bio-equivalence, safety and efficacy of copy-cat versions, either in India or abroad," industry representatives said.

"There are issues regarding safety in terms of the controlled environment in which the drug is manufactured, the ability to manufacture a consistent product each time. A biotech drug is susceptible to variables," they add.

Meanwhile, top brass in the Union Health Ministry point out that the report will now be discussed internally before a final directive is given from the Ministry.

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