Govt to deal firmly with those exporting spurious drugs

25 February 2015 | News | By BioSpectrum Bureau

Govt to deal firmly with spurious drugs

While making a statement in Parliament on February, 24, 2015, on the issue of export of spurious drugs, Mr JP Nadda, union health minister gave details of the steps taken by the government to curb it.

His detailed statement mentioned that isolated cases of export of drugs of sub-standard quality by some Indian pharmaceutical companies have appeared in the media and on the websites of the regulatory authorities of foreign countries, etc. from time to time. These include the websites of United State Food and Drugs Administration and Medicines and Healthcare Products Regulatory Agency, United Kingdom. Based on the samples taken by Central Drugs Standard Control Organization during 2011-12 to 2014-15 (up to September, 2014), 0.03% samples were found to be spurious or adulterated and 3.33% samples were found to be not of standard quality. Such medicines are not allowed to be sold either in the domestic or in other markets.

Samples are drawn by the officers of the Central Drugs Standard Control Organization (CDSCO) and State Drug Regulatory officials regularly and these are tested at the drug testing laboratories. In cases, where samples are not found to be conforming to quality, appropriate action is taken by the State Drug Regulators. These include suspension, cancellation, rejection or debarment of the license.

In order to check the problem of spurious/sub-standard drugs in the country, a number of steps have been taken by the Government. These include amendment to the Drugs and Cosmetics Act, 1940 which provides for stringent penalties for manufacture of spurious and adulterated drugs. Through that amendment, some offences have also been made cognizable and non-bailable. Further, 21 States/UTs have already set up Special Designated Courts for trial of such offences and the structures in the CDSCO have also been strengthened.

Black marketing of life saving drugs


Mr Nadda also revealed that health ministry does not have any information about black marketing of drugs. However, the State Drug Controllers are empowered under the Drugs & Cosmetics Act, 1940 and Rules thereunder for initiating action against such unauthorized activities.

The health minister elaborated, "Pricing of drugs is dealt with by the Department of Pharmaceuticals. As per information provided by that Department, 51 cancer medicines are included in the scheduled category of Drugs Price Control Order (DPCO) out of which National Pharmaceutical Pricing Authority has already notified the ceiling prices of 47 cancer medicines. No person is authorized to sell formulations at a price higher than the ceiling price of scheduled formulations fixed under DPCO, 2013. In respect of non-scheduled formulations, not covered under price control, manufacturers are not allowed to increase the price beyond the permissible limit of ten percent on a year to year basis under the provision of DPCO, 2013."



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