The development comes after drug regulators in seven States across India sent notices to 18 pharmaceutical companies, saying that nearly 27 medicines manufactured by these companies had failed quality tests.
According to a report in a leading English daily, while the crackdown against substandard medicines has been under way since March this year, only one out of the 18 companies had recalled a substandard drug from the market and two had stopped distribution of batches of inferior quality drugs.
Regulator is watching
“We have asked for reports from the State drug regulators. The message is simple, the regulators are watching. This is routine procedure and we have been doing it from time to time,” said Mr Mishra. The drug regulators of Karnataka, West Bengal, Andhra Pradesh, Maharashtra, Gujarat, Kerala and Goa have pointed out various deficiencies with regards to labelling of the drugs and dosage etc.
Meanwhile, the report on nearly 48,000 drug samples surveyed as part of the National Drug Survey is expected to be tabled in the winter session of Parliament. The 400-page report covers the survey over two years by the National Institute of Biologicals (NIB) to gather evidence about the extent of spurious drugs in the Indian markets. This is the first pan-Indian survey, said Dr G.N. Singh, Drug Controller General of India who heads the Central Drug Standard Control Organization (CDSCO).
According to National Centre of Biotechnology Information (NCBI), in 2009, the Indian government sampled 24,136 drugs of 62 brands in a nationwide survey. “Samples were drawn from over 100 pharmacy outlets from various regions of India, which belonged to nine therapeutic categories of 30 manufacturers. Survey affirmed that only 11 products (0.046 per cent) were spurious,” stated the paper by A.N. Khan and R.K. Khar.
In the last few years, CDSCO has been cracking down on companies that make falsified/spurious or substandard drugs. According to the health ministry, 35, 35, 34 cases of substandard quality were reported during 2009-2010, 2010-2011 and 2011-2012, respectively.
Pharm.D @ SRIPMS-CBE-TN