Spurious drugs spoil India- part 2

Even when spurious drugs do not endanger life, they can leave the patient seriously ill and those with inadequate potency do bigger harm to the society in general. Drug resistance develops when patients consume drugs with inadequate potency forcing them to look for costlier new generation drugs. And these patients could put the entire society at risk by spreading drug resistance. Unlike other cases where the consumer knows his intent, the spurious drug industry thrives on consumers' ignorance, lack of stiff penalty for indulging in such activity and finally on lax regulatory system. Packaging is so nearly perfect that distinguishing a spurious drug from a genuine one is almost impossible as the fake makers are investing nearly 20 percent of the total investment in packaging.(a recent finding).

As I said earlier, the consequences are not restricted to consumers or the patients alone. With a market share of nearly 20 per cent of the total drug market in India (it is worth nearly Rs. 4000 crores) the spurious drug industry's thirst for more is clear to see. It has already set its eye on the export market and succeeded in taking spurious drugs beyond our shores.Many are sent overseas, too especially to the states of the erstwhile Soviet Union. Several people have been arrested while trying to smuggle out spurious drugs in bulk to these countries. Africa and Latin America have taken cognizance of the increased export of spurious/sub-standard drugs from India and have started complaining about it. And worse, nearly 3-5 per cent of the drugs landing in the U.S. are spurious. The U.S. has already put India in the 301 watch list threat some months ago. If implemented it would totally ban export of drugs from India and sound the death knell for the Indian drug industry.

Punjab, Haryana, Himachal Pradesh, Delhi, Uttar Pradesh, Bihar, Gujrat and to some extent Madhya Pradesh have the bulk of spurious drug manufacturing units. In UP, the major sale of spurious drugs is in Agra, Lucknow and Varanasi.The Indian pharma industry, including those manufacturing fakes and spurious drugs, is growing at the rate of about 20 per cent annually, which means that every year the chances of your buying a medicine that can do more harm than good (as some even contain toxic material) are also rising proportionately. According to an industry estimate, 15 percent of the drugs and pharmaceuticals sold in India are either spurious or substandard and the percentage is only growing with no effective check on this illegal activity. Increasing pressure of a powerful industry lobby on the government to allow certain drugs and cough preparations as OTC and the government's move to classify a set of ayurvedic preparations as food supplements may add a new dimension to the problem of spurious and substandard drugs in future. By permitting drugs for minor ailments as OTC and allowing them to be sold by stores other than medical shops, monitoring of their safety and efficacy will be almost impossible for state drug authorities just because of the huge number of such stores in each state

In India, drug pirating is made possible by the existed patents regime. These laws offered protection only for manufacturing processes and not for the products themselves. Besides, protection for process was also available for a period of seven years, unlike in the West, where patent protection is for a period of 20 years. As a result, under existing Indian patent laws, Indian drug companies were well within their rights to reverse-engineer well-known brands and sell them as their creation. Significantly, drug piracy of this kind is reduced from 2005, when India and many other developing countries extended process patents to products too under the World Trade Organization. In view of this development, some Indian drug companies are already moving away from the manufacture of generics to the development of new drugs through research and development

to be continued..