NEW DELHI, 22 AUG: Almost one in three drugs (36%) found "not of standard quality" from across India last year were from Maharashtra (23%) and Tamil Nadu (13%) alone.
Around 9.2% of the rest of the sub-standard quality drugs were from Kerala, Gujarat (8.5%), Karnataka (7.2%), Uttar Pradesh (6.9%), Jammu & Kashmir (6.08%) and Rajasthan (5.8%).
Union health minister Ghulam Nabi Azad said on Tuesday that of the 48, 082 drug samples tested by state drug controllers between 2011 and 2012 (till October); 2,186 samples, or around 4.5% failed the quality test.
In comparison, 4.9% of the samples tested in 2009-10 and 4.7% in 2011-11 were sub-standard. Of these, around 133 samples — almost 6% — were found to be spurious or adulterated, the minister said.
The maximum number of samples tested were from Maharashtra (6,928), followed by Karnataka (5268), Andhra Pradesh (4,758), Tamil Nadu (4,110), Kerala (3,904), Punjab (3,031) and Gujarat (2,874).
A very few samples were tested in Delhi (283) of which only 13 samples — around 4.5% — were found to be sub-standard.
As far as spurious or adulterated drugs are concerned, which has no active ingredient or is an expired drug that has been re-labeled and sold, Gujarat recorded the highest number of such samples at 64, followed by Maharashtra (19), UP (11) and Delhi (9). Union health ministry officials say there are more than 10,000 drug manufacturers and more than six lakh outlets that sell fake drugs.
Experts say acute shortage of drug inspectors (DI) is hampering the nation's fight against spurious and fake drugs.
The Central Drug Standard Control Organization (CDSCO), which lays down standards of drugs, estimates that the nation requires 3,200 DIs for its six lakh chemists, but only about 1,000 DIs are available. The size of India's pharmaceutical industry is pegged at Rs 90,000 crore of which 40% is exported.
CDSCO estimates that in the next five years, drug exports may rise from Rs 42,000 crore to Rs 2 lakh crore.
Azad said "spurious drugs not only affect the citizens' health but also the prestige of the country's pharmaceutical trade interests."
The Union health ministry had earlier formulated a whistleblower policy — to handsomely reward both public and officers who help seize spurious, adulterated and misbranded drugs, cosmetics and medical devices. The policy stipulated a reward of maximum of 20% of the total cost of consignments seized as payable to the informer that won't exceed Rs 25 lakh for a case. However, the policy fell flat.
The working group on health for the 12th five year plan has recommended setting up of eight new Central Drugs Testing laboratories for Rs 320 crore, besides upgrading the six existing ones for Rs 15 crore each.
Although many labs have facilities for testing of drugs (quality), they aren't equipped to test contaminated substance in drugs, it said.
It has also suggested setting up of a state-of-the-art pharmaceutical research laboratory to carry out analysis of drugs at a cost of Rs 50 crore.
It has also suggested setting up of mobile drug testing laboratories to curb spurious drugs' menace. The health ministry estimates that 5% of drugs in India are counterfeit, while another 0.3% is spurious.
A counterfeit medicine has no active ingredient, or is an expired drug that has been re-labeled and sold. It is different from a fake drug that may not resemble the original.
A Planning Commission's high-level expert group (HLEG) on universal health coverage recently brought to light the widespread use of irrational drugs. "The market is awash with irrational, non-essential and hazardous drugs," it said.
Drug Controller General of India (DCGI) estimated that about 46 banned fixed dose combination drugs (FDCs) continue to be marketed irrespective of the ban.
"There is a clear need to phase out hazardous, non-essential and irrational medicines and irrational Fixed Dose Drug Combinations. Recent reports on anti-microbial drug resistance in India clearly point to the need to end the irrational drug prescription and dispensing practices," the panel suggested.
According to The Lancet, in developing countries like India, 10%-30% of medicines are feared to be counterfeit.
World Health Organization (WHO) says that counterfeit drugs proliferate because the profits are huge and the risks are low. Studies estimate fake medicines rake in upto $80 billion a year, but penalties for getting caught are relatively modest.
WHO's latest estimates show more than 30% of the medicines sold in south-east Asia are counterfeit. In emerging economies, WHO pegs that figure at 10%.
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