The Hindu Business Line : Reinstatement of anti-retroviral drugs by WHO evokes positive response

THE reinstatement of two generic anti-retroviral drugs manufactured by the Indian generic drug maker Cipla to the World Health Organisation's approved list of medications for HIV/AIDS patients has generated a positive response from various quarters.

Thus, Financial Times has quoted Mr Daniel Berman, HIV/AIDS coordinator for Access to Essential Medicines (a Medicins Sans Frontieres project) as saying: "This is extremely good news. It shows that although there have been problems, the WHO is raising the bar and companies are responding in improving quality."

Agence France-Presse has also reported Mr Lembit Rago, WHO coordinator for essential medicines and drugs, as saying: "It could be seen as a short-term pain, but I think it will be outweighed by a long-term gain. The whole pre-qualification process has in a way been a turning point... in terms of putting much more emphasis on the quality of drugs than has been done before."

The statement by the WHO Assistant Director-General (Family and Community Health), Ms Joy Phumaphi, that the organisation will consider re-enlisting the remaining banned aids drugs manufactured in India if the laboratories producing them meet the set international standards also affords a degree of relief to all those who were appalled by the withdrawal of anti-retroviral AIDS drugs manufactured by Cipla, Ranbaxy and Hetero from the WHO's approved list.

However, the question persists: How did things go so wrong in the first place?

The pharmaceutical companies are trying to lay the blame for the shameful episode at the doorstep of the Contract Research Organisations (CROs) which, they say, failed to adhere to the required standards in conducting the bio-equivalence studies, which ensure that a generic copy of a patented product has all the properties of the original - but this exercise is futile in as much as the CROs are agents of the pharmaceutical companies and the drugs their properties.

To put the whole matter in perspective, the Indian pharmaceutical industry has been successful in supplying generic bulk drugs and formulations to developed countries with extremely high regulatory standards - and yet, in June last, WHO had removed Cipla's versions of lamivudine and zidovudine from its approved HIV treatment list, citing inadequacies detected in the course of an inspection of an independent laboratory hired by the company to conduct tests to determine whether the generic drugs were equivalent to brand-name versions.

Subsequently, Ranbaxy had removed all seven of its generic antiretroviral drugs from the WHO list after discovering discrepancies in bioequivalence tests. Hetero Drugs too had withdrawn all six of its anti-retroviral drugs from the WHO list because of deficiencies in the data submitted and because the laboratories it was using to conduct bio-equivalence tests were not compatible with current standards.

WHO grants pre-approval for a drug on the basis of information about it supplied by the manufacturer and it is on the basis of this pre-approval that the drug is marketed. The WHO audit of the CRO involved, its documentation, the processes that it followed and so on, comes later.

Observers are hard put to understand why these companies did not pull out their drugs prior to the WHO audit of the CROs involved even though they must have known that the bio-equivalence studies would not stand up to close scrutiny.

While the Indian drug companies involved cannot escape responsibility for what happened, the fact of the matter is that the withdrawal of the drugs was a disaster waiting to happen, given the manner in which the office of the Drug Controller General of India functions. Even after the amendment of Schedule Y to improve the quality of clinical trials, the regulator continues to be extremely lax in its functioning.

To make matters worse, there are two sets of standards in India - one structured for the satisfaction of regulators in developed countries and the other for the Indian regulator. It is because of this duality in standards that the country's pharmaceutical industry is able to bring out the best and the worst quality drugs.

The CROs too exploit the two-standard system to their advantage. In the case of the generic anti-retroviral drugs under discussion, the CROs had studied them about two years ago when they were not certain where the WHO fitted into the scheme of things and when the WHO was manifestly in a hurry to get cheap drugs into the market in order to fight HIV/AIDS.

In the end, the CROs decided that the WHO could be treated on par with the Indian regulator... If they had been set right on this point by the drug companies, the Indian pharmaceutical industry could have escaped the ignominy that it has now suffered.

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