Good manufacturing practices norms, which are currently holding sway across the Indian pharmaceutical industry, have categorized the manufacturing sector into three distinctive groups: those who had already complied with the international quality standards; those who are in the process of complying and those who are yet to be complied.
The first set of companies, that evidently includes the MNCs and a clutch of top-wrung players in the industry who have been driving their bottom lines with a sturdy overseas business, had started adapting to the world class quality standards far back. Midcaps and a handful of small-time players have either just completed the upgradation process or are busy in their work. The third and, of course, the largest section (in terms of number) of the small scale enterprises still find themselves in the twilight zone of confusion. If a wide majority among them are in real earnest to find the wherewithal for the task in the extended time span of another year, others still think they do require much more time to commit to the revised GMP requirements.
The general sentiment, meanwhile, in the industry is that all those players who are serious in the business have realized that there is no substitute for quality. Also, they understand that quality is going to be the only criterion in the emerging, competitive marketplace. “There can never be a going back from the quality standards norms. If you want to sell your products it has to have certain quality. Simple. Why does anyone need so much of a time to realize this simple fact,” remarks an industry observer.
Unlike any other product, medicine cannot be regarded as a commodity. It seeks to address an anomaly, a disease condition. So, we can't afford to compromise. Quality becomes paramount here, avers Dr M Venkateshwarlu, Deputy Drug Controller, West Zone. If not now then when are we going to have good manufacturing practices for pharmaceutical products, he asks.
According to him, a good majority of manufacturers have realized this fact and emerged with competitive quality skills in the recent years. More than 70 per cent of manufacturing units operating in Maharashtra have modernised their facilities in accordance with GMP standards set by WHO.
Currently, 40 new GMP-complaint manufacturing units are coming up in Baddi , Himachal Pradesh alone. This itself is a telling example how the future scenario takes shape.
The trend is more or less same in other leading states like Andhra Pradesh, Gujarat, Bangalore, Delhi as well as where the pharma industry has got a definitive foot-hold.
It is clear that the GMP tide has already swept the manufacturing sector. The whole world realizes and swear by the word quality. Those who still miss this fact will definitely fall by the wayside. ``GMP norms have come into being in 1982. Now it's more than two decades have passed. At this point of time what should we tell those people who still seek more time,'' asks a senior official from the Central Drug Standard Control Organisation (CDSCO) West Zone, Mumbai.
You don't require a fortune to make your establishment compliant with the GMP norms. Even small companies can do it. ``It's not the question of resource alone. But the right mindset. All you need to have is a basic understanding of science and a bit of common sense,'' he comments.
Even as many a firm find it difficult to cope with the WHO GMP stipulated norms, one section of the industry appears to have strong reservations against the way it happens in India. The ongoing efforts towards good manufacturing practices is much a diluted version of what is being practiced in the highly regulated markets, they complain.
"Is it realistic to have a standard which falls way behind the norms set by the very same markets where you want to foray into? Further diluting the stringency you are placing yourself on a loser's wicket. You make a product of one standard while the world is looking for a different one. How can they compete each other in the global market place?'' asks a research officer who works with an MNC, based in Mumbai.
Brijesh Regal, CMD of Apothecaries Limited-- a clinical research firm based in New Delhi also cherish a more or less similar view. ``Quality standards set by US FDA or MHRA of UK go far beyond the norms we are trying to implement here in India,'' he comments.
However, Dr Venkateshwarlu's opinion is that the principles of GMP is the same anywhere. It is only the levels of interpretation that usually differ. ``It all depends upon how do you interpret the norms stipulated by the GMP. And how you implement them,'' he explains.
There are two things that come foremost: safety and efficacy. Standards set by the regulatory bodies in certain regulated markets go beyond safety. They attribute higher significance to efficacy of the product as well. Specifications will be different in accordance with the emphasis placed on each of the aspect.
Better understanding of the principles can facilitate smooth implementation. If the revised schedule M is implemented as a law, every unit will have to invest anywhere from Rs 20 lakhs to Rs two crores. SSI units can hardly raise this kind of funds overnight, says an official from Confederation of Indian Pharma Industry (CIPI).
No company is against implementing quality standard norms in principle. But the only hurdle remains to be the funds which they think they cannot quickly source from. ``If some financial institutions or credit agencies or even an industrial body with a credit corpus set for the purpose can come forward to provide assistance, we will only be happy to have a modern production set-up,'' smiles a small-time entrepreneurs.