Only a couple of days left for the yet-to-be-complied Indian drug manufacturers to meet the GMP ultimatum. After extending many times over, June, 30, 2005 has been fixed by the government as `the final deadline', heeding to the plea of small scale drug industry, for complying with the WHO authored Good Manufacturing Practices. And the word is almost spread that there would be no further lease of time in the name of another extension.
Despite tough opposition from small-scale entrepreneurs, the pharma industry in general, has evidently drawn a consensus on the necessity of quality standards for drug products. Indian pharma, which exports nearly half of its produces to both regulated and unregulated markets around the world, knows full well that quality is an essential parameter. No section of the industry has a difference of opinion that quality should be the ultimate mantra to thrive not only overseas but in the highly competent domestic markets, as well.
"If not getting everyone compliant, the repeated extensions have served one purpose. Almost all drug makers, big or small, now understand that revised Schedule M norms are not something undesirable being forced upon the industry, but as something essential for their own survival, for their own merit," reveals a senior official with Central Drug Standard Control Organisation (West Zone).
True. There is no confusion even amongst small scale industries (SSIs) that GMP is a must. ``We are not against implementing Schedule M norms. We are only looking for a little more time so that we can also find the resources to modernize,'' they argue. Moreover, there is no funding mechanism to support the SSI units. ``Despite our repeated appeals, the Government never bothered to create a subsidized fund like the Technology Upgradation Fund Scheme, which helped textile units to modernize,'' they complain.
Now hundreds of units, which borrowed funds at unaffordable interest rates to comply with the deadline, are facing closure because of the MRP based excise duty norms. Had the authorities thought about the affordability and future business prospects of small-scale units, when they brought in the mandate on Schedule M?, asks T S Jaishankar, chairman, Confederation of Indian Pharmaceutical Industries (CIPI-ssi).
"Now more than 5000 units, which invested over 7500 to 9000 crores of rupees, are on the verge of closure. More than nine lakh workers and their families dependent on these units are being thrown out to the streets for further livelihood," he bemoans.
According to him, neither the govt, nor the powerful organizations catering to the industry, cared to study what will happen to availability and affordability of drugs in India, especially in remote villages after such a massive closure of SSIs.
However, leading industry associations like Organisation of Pharmaceutical Producers of India (OPPI) is of the view that closure of pharmaceutical units which are not complying with Schedule M norms may not cause any shortage of drugs in the country. "I do not think that if units, which cannot adopt Schedule M, are closed down it will lead to shortage of medicines. Other good manufacturers would be able to meet the demand fully with improved quality of medicine," says Ranjit Shahani, president, OPPI.
Indian Drug Manufacturers' Association (IDMA), which represent a good proportion of medium and small-time players, also maintains that all the drug makers should conform to Schedule M of the Drugs & Cosmetics Act. ``We are not in full favour of seeking another time extension for Schedule M compliance. Such an extension is practically impossible now. We have already asked our members to gear up,'' avers Daara B Patel, secretary-general, IDMA.
Industry observers strongly feel that there is no point for buying more time in this regard. Sufficient timeline are given and we are already late. Moreover, WHO GMPs being implemented here are, in fact, a much-diluted version of current good manufacturing practices adopted in regulated markets. These standards could well be a practice worldover tomorrow, including the developing and underdeveloped countries.
However, the SSI sector considers that it is being highly discriminated against. Denial of more time and the propaganda on their lethargy and mindset that is averse to change are nothing but a well designed ploy by the doyens of the industry to wipe out the small scale sector. They are decided to fight it out exploring legal options, if need be.
CIPI-ssi, has already instructed its state level associations to seek legal opinion on approaching respective high courts to obtain a complete stay on Schedule M, in the wake of the recent Calcutta High Court order granting stay on implementing clauses related to large volume parenterals, based on a petition filed by a local manufacturer.
Toeing the line, the Federation of South Indian Pharmaceutical Manufacturers Association (FOSIPMA), the joint association of pharmaceutical manufacturers in Kerala, Karnataka, Tamil Nadu, Andhra Pradesh and Pondicherry is also exploring options to approach the Madras High court to obtain a stay on revised Schedule M norms for formulators.
Aswini Kumar, Drugs Controller General of India (DCGI), nonetheless, maintains that the court order is unlikely to affect the mandate given to the non-complainant GMP units. "It is not an issue at all. Courts cannot pass judgment on technical matters like this and stay is not a verdict. I am yet to get a copy of the court order. If an association obtained a stay in that state, it will be restricted only to the jurisdiction of that state and if it is an individual manufacturer, it is restricted only to that manufacturer. As of now, all the manufacturers have to comply with the deadline."
Even if they move courts, it can only provide a temporary stay as these quality norms are for the larger interest of the companies and the country. Those firms which may lose license due to non-compliance, can take their own time and generate adequate resources to modernize as per GMP terms and start all over again, if they are really serious, observers opine.