The Maharashtra Food and Drugs Administration (FDA) has 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, sources said.
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 had collected the 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 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 Ghaziabad, Uttar Pradesh for testing.
Interestingly, the sample testing by the FDA has revealed that most of the drugs which come under the substandard category and sent for prosecution are manufactured in Baddi where the plants are set up as per the GMP norms and conforming to international standards. Though the substandard medicines are manufactured from all over the country, most of the 633 substandard drugs found during the year were from Baddi, an FDA source said.