Jagmohan Rai Agrawal, is Chairman of Madhya Pradesh Small Scale Drug Manufacturers' Association, which is one of the active state-level organizations of the pharmaceutical industry. The association was the first to complaint about the lack of proper SSI representation in the Mashelkar Committee on spurious drugs. It has also been vociferous in highlighting the unethical practices of pharma majors and is perhaps the only association that had countered the allegations of Indian Pharmaceutical Alliance sponsored intelligence team about the presence of spurious drugs in the same fashion.

Jagmohan Rai Agrawal, who is also Managing Director of Bright Drug Industries Limited, Indore, spoke to Joe C Mathew of Pharmabiz.com on the views of his association on some of the current issues facing the pharma industry.

What is the government's attitude towards the small-scale drug manufacturers of the country? Do you think that the SSIs in drug sector have completed its historic role and are destined to give way to big pharmas?

The government's attitude towards the SSIs is not at all encouraging. Several of the recent government directives are anti-SSI and are intended to push the SSIs out of fair competition from the drug sector. They have been imposing lot of rules that are unnecessary and taxing. What we need is not just reservation; we need to be given a level playing field. Given equal opportunities, we are willing to compete even with the pharma giants.

About its role and relevance, it would be impractical to say that SSIs had it for now and should leave lock, stock and barrel. In the era of sophistication and globalisation, this sector too would try to evolve and match with the times. Efforts have already begun.

The menace of spurious drugs is one of the most discussed issues today. A central legislation to bring in stringent laws against manufacture and sale of spurious drugs is almost certain. What are your observations in this regard?

Let there be no doubt that manufacture of spurious drugs is a clandestine activity and there is no authentic data to support the claims on the spread of spurious drugs in the country. Whatever data available is also not clear on various technical grounds. The rough surveys suggest that on an average 0.25 per cent drugs are spurious and after testing, 8.9 per cent are found not of standard quality. However, there is no bifurcation that the drugs found spurious or not of standard quality are products of SSIs, PSUs or MNCs. Also, a good quality drug when placed under adverse temperature, pressure conditions might
lose its standard quality. The test reports are also subjected to errors.

Most of the SSIs are allegedly resorting to the manufacture of look-alike drugs. Do you agree with this perception? If so, do you consider it ethical on the part of SSIs to go for a look-alike brand even if they have the product approved by some ill-informed state drug control administrations?

There are 300 corporate sector units out of which 80 per cent can resourcefully play with brands for more growth and more profits. They also operate with established brands and at times misbrand their products to cash on the popularity of a brand name. The question ahead of them is profit or more profit? The 20 per cent of the industry -- the SSIs -- are faced with the question of survival. After being driven out of the tender process due to stringent, unnecessary norms, some of them might have resorted to the manufacture of look-alike products. But when the big players themselves are manufacturing look-alike of their popular brands and they go unchecked, why just blame the SSIs?

The big companies change compositions and continue to use the same brand name, why is there no action taken against them? It's not just a problem of ethics. It's a question of survival for the SSIs. Suppose we agree that SSIs should not deviate from ethical practices, the same
set of morals should be enforced on the big players too.

Replacing the composition of existing fast moving brands without changing the brand name is a common practice in the country. Do you feel that the practice can create the same harm as in the case of a look-alike drug?

Definitely, every person who purchases a drug is expecting a cure. He believes in the prescription of the doctor and the efficacy of the medicine. What if the branded product that he is purchasing is no more the same drug, or no more contains the same therapeutic value? This is nothing but betrayal of the patients' faith; and is also unethical.

Delhi has made trademark search mandatory before sanctioning any new marketing approvals. How will it affect the prospects of the SSI sector?

As on today, the sanctioning of brand names does not fall under the purview of the drug authorities. Suppose I acquire a brand name and after some time receive a notice from the trademark authorities about infringement of trademark, is there any legal validity for the permission given by the drugs department? Will the department take the responsibility? It will simply lead to delay in the sanctions but nothing more.

The confederation of SSIs, of which you are an integral part of, is lobbying for an extension of the deadline for implementing the revised Schedule M. Do you think a revision would help the cause of SSIs?

A revision of Schedule M would be in favour of the SSIs. We have requested an extension of five years and have asked the authorities to omit unrealistic provisions. Also, looking at the government's attitude, it is very important that the SSIs are provided with a proper atmosphere for growth.

What are the major issues before the SSI sector? What would you expect from the government to tide over the crisis of the present times?

An SSI was first defined as a unit with an investment of Rs 1 crore on plant and machinery. Later it was increased to Rs 3 crore but was soon brought down to Rs 1 crore. There is a pressure now to raise the investment limit to Rs 5 crore. This has to be checked. The Schedule M should be revised, as it is another issue, which the industry is facing now. The government should understand that growth of the sector is very important. There has to be an atmosphere of equal competition and equal opportunities for growth. Let the government create the atmosphere, SSIs can manage the rest.
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(Readers, please note, the above interview was taken before the recent developments of legislation seeking death penalty for spurious drugs manufacturers introduced in parliament & Schedule M deadline extension)