Even as the representatives associations of the small scale pharma sector across the country are voicing concern over the "charges and complaints" made against them by the pharma majors with regard to their alleged "role" in manufacturing spurious drugs, the new inter-ministerial, multi-disciplinary committee formed by the Ministry of Health and Family Welfare is planning to recommend major changes in the existing laws to make drug regulation and quality control monitoring very stringent. The committee has representatives from almost all sectors, perhaps the bulk drug-manufacturing sector being the only exception. The SSI sector has seen red in the move, which they feel, if not properly handled, would result in the formation of new laws which could be used against them by the major pharma companies.

In an exclusive interview with Joe C Mathew of Pharmabiz.com, Rakesh Arora, vice president, All India Small Scale Pharmaceutical Manufacturers' Association and managing director, Wings Pharmaceuticals Pvt Limited explains the association's stand on the issue. AISSPMA is representing the high-power committee on behalf of Indian small-scale pharma sector. The association is 25 years old and has over 1,000 members from across the country.

How does AISSPMA view the recently formed Mashelkar Committee?

The formation of the committee was based on the demands from the big players in Indian pharma sector. Indian Pharmaceutical Alliance, the group of major Indian pharmaceutical companies has a strong presence in the committee. It has representatives from all sections of the industry. The objectives of the committee are to recommend a new structure for the drug regulatory system, strengthen the drug regulatory infrastructure in Centre and States, evaluate the extent of the problem of spurious and sub-standard drugs, recommend changes required in the Drugs and Cosmetics Act, 1940 as well as in judicial procedure related to offences committed under this Act and to recommend steps to be taken by the industry to tackle the problem of spurious drugs.

On the whole, it looks good to have a review, but the association feels that the existing rules are good enough to handle most of the issues raised above. What we lack is the will to implement our own regulatory measures.

How serious is the spurious / sub-standard problem in the country? What would be association's recommendation regarding this particular issue?

We condemn the act of spurious drug manufacturing. The association would support any initiatives taken to check the flow of spurious drugs in the country. We would also call for speedy trials and speedy conviction of spurious drug cases. But we disagree with the attempts to mix up issues related with spurious drug manufacturing, counterfeit drug manufacturing, sub-standard drugs etc.

The spurious drug racket has developed over many years and it will be foolishness to expect to wipe out the menace at one stroke. A joint and sustained effort of the government, industry and trade is required to counter this problem. The big pharma players seem to be ignoring the fact. According to them, most of the SMEs in this country are spurious drug manufacturers. They have gone on record even during the committee meeting that the SMEs, started with just one to 1.5-crore investment, are behind the entire not-of-standard quality and spurious drug production in the country. This is absolutely baseless. We may not have the same infrastructure they have, but one cannot spread a general idea that SSI sector in pharmaceuticals is a criminal industry.

We agree that spurious drug manufacturing is a crime. But we cant put an end to it in one day. You can minimize this, but it should not be by blaming people who are doing ethical business.

Any suggestions from your part to strengthen the vigil over spurious drugs?

Law can be amended. However, it should be after categorizing the nature of various cases that can come under the purview of the law. There are substandard drugs made by unlicensed persons, made by licensed manufacturers without the license agreement from the patent holder, drug manufactured by licensed manufacturer in his factory in his brand named or declared as sub-standard / spurious and counterfeit drugs manufactured by unlicensed persons in unlicensed premises. The Law should be clear in the case of each instances and separate treatment ensured. There has to be a provision where a drug, even if its assay and quality are good enough, can be termed spurious, if it is manufactured by unauthorized persons in unlicensed premises. Law should be in clear words. By virtue of any trademark clash nobody should be penalized. The intention of the sub standard manufacturer should be judged first.

The present procedure with which we deal spurious drug cases is very lengthy. We should admit the fact that corruption is the root problem in our country. Even if you catch someone red handed, an efficient lawyer gets him freed from the prison within days. What follows is a lengthy litigation, which may take 15 to 20 years. By that time, the evidence is spoiled, or the culprit bribes his way out. We should also realize that our judiciary is often not prepared or well versed with the complications of the drug laws.

A special tribunal for spurious drugs would be one of the major demands of the association. Evan a tribunal for two or three states would result in speedy trials. It would also ensure speedy conviction. We strongly believe that person responsible for spurious drug manufacturing should be put behind bars within no time. The crime rate is increasing in the absence of such measures.

State level drug advisory boards and citizen charters are essential. There has to be regular interaction with the industry and the drug regulatory authorities participation of the society is also important.

Formation of National Drug Authority is one of the items on the agenda of the committee. What would be your response to such an authority?

Centralized control of drugs cannot be effective. The strengthening of state drug administrations is the only practical option. Give them more facilities. Reward the informants and keep the information confidential. This is what one should do. Police should be involved in all the action.

Uniform implementation of law is another issue which has to be dealt with seriously. Today we have five to six state drug control administrations who are enforcing the rules strictly, but in other states, the spurious drug manufacturers are left to play freely.

With the new Schedule M requirements calling for WHO GMP approved facilities, do you feel that the SSI sector should give more serious attention to the comments from the big pharma sector?

The Schedule M deadline is nearing. The SSI sector is trying to comply with the new norms. But we don't think the government would ask all others who fail to comply with the norms to close down immediately. We are looking for the cooperation from the department. There should certainly be some time relaxations. We are serving rural India. Small-scale units give medicines to those doctors at a very economical price. This factor cannot be ignored. Volume wise 60% of the drugs consumed in the country are produced by the SMEs. We function on very low profit margins, which is ultimately helping the patients. Multinationals cannot have the drug trade without SSI sector. Given all these facts, it is difficult to think that the government would take any abrupt action against the small-scale units in the country.