More than 100 violation cases were initiated against wholesalers and distributors of pharmaceutical products in Tamil Nadu during the last year by the state drugs control department and all the cases were filed before respective area courts.

Correspondingly, the whip of the regulators have fallen on the manufacturers of drugs during this period and around 100 prosecution cases were filed against manufacturing companies for violation of section 18 (a) (i) of the Drugs and Cosmetics Act. Majority of the cases were for manufacturing ‘not-of-standard-quality’(NSQ) drugs.

In all the cases, the respective courts punished the wholesalers and the manufacturers for violation of various provisions, said M Adbul Khadar, state director of drugs control.

Sharing the details with Pharmabiz, he said the major offence by the wholesalers was the violation of Rule 65 (9) (b) of the Act. During inspections, it was found that several wholesalers in Chennai, Coimbatore, Madurai, Salem, Namakkal, Thirunelveli and in other various cities have supplied drugs to medical practitioners and hospitals without getting signed orders in writing.

The Act says that “the supply of drugs specified in Scheduled H or Schedule X to registered medical practitioners, hospitals, dispensaries and nursing homes shall be made only against the signed order in writing, which shall be preserved by the licensee for a period of two years”. The violators of this provision will be punished as per section 27 (c), added P Sivabalan, the deputy director of the DCA.

The director Abdul Khadar said strict vigil is now kept on all the manufacturing companies and the products coming from other states are also under regular scanner of the regulators. Around 100 cases have been filed against manufacturers in a short span of nine months from April 2014 to January 15 this year. There were two big players also in the list. The section 18 (a) (i) says that “no person shall manufacture for sale any drug which is ‘not-of-standard-quality’ (NSQ) or misbranded or spurious”.

Similarly, two manufacturers of cosmetic products were also prosecuted and a host of samples were taken for testing during inspections at the sales counters and manufacturing units.

Prosecutions were also initiated against 12 manufacturing companies of Indian medicines under DMROA for publishing misleading advertisements in Tamil and English magazines about products claiming cure for erectile dysfunction, diabetes, obesity, etc.