The Maharashtra Food and Drugs Administration (FDA) has asked the Drug Controller General of India (DCGI) to take 'appropriate punitive action' against drug manufacturers whose products have repeatedly failed in the sample testing conducted by the FDA during the last three years.
As many as 29 drugs of two companies have found repeatedly failed during the last three successive years in the sampling test conducted by the Maharashtra FDA. Both the manufacturers are based in Himachal Pradesh. While the state FDA has taken action against the manufacturers in the state, the drugs are still being supplied in the state and outside as their licenses have not been cancelled in the state where it is being manufactured.
Sources said that though the Maharashtra FDA has written to the drug controllers of the concerned states, any punitive action against the habitual defaulters is still awaited. As the issue drags on, the Maharashtra FDA has now asked the DCGI to take note of the issue and take appropriate punitive action against the companies.
Earlier, the Maharashtra FDA filed criminal cases against manufacturers of 108 drugs for manufacturing and selling sub-standard medicines in the state during the financial year ended March 31, 2008. Most of the substandard drugs are manufactured in the country's biggest pharma hub at Baddi in Himachal Pradesh. Most of the cases are in court.
According to data available with the FDA, a total of 633 medicines failed the drug standard testing done by the FDA during the year. The FDA had collected a total of 7038 random samples from different parts of the state for testing during the period and out of that, 633 drugs failed to stand by the prescribed quality standards, amounting to around 9 per cent of the total samples.
But the FDA could file criminal cases only against 108 drug manufacturers because as per a DCGI circular, the state drug departments should initiate prosecution against the manufacturers whose samples are found to contain less than 70 per cent of the active ingredients. There were 108 such cases which were filed with the Judicial Magistrate First Class. Once proven guilty, the manufacturers of these drugs may get 1 to 3 years imprisonment or fine or both.
The FDA collects samples from different sources like government and private hospitals, retail chemists, wholesalers and doctors who dispense medicines from their dispensaries. Sources said that most of the sample medicines were drawn from the hospitals, especially the government-run hospitals, as government hospitals are considered to be the breeding ground for such substandard medicines.
After collecting the samples, the FDA would send the sample drugs to its testing laboratories in Mumbai and Aurangabad. In the case of homoeopathy medicines, the sample drugs are sent to the government laboratory in Gaziabad, Uttar Pradesh for testing.