The department of drugs control in Tamil Nadu (TN DCA) has prosecuted six pharma companies for manufacturing spurious drugs in the financial year 2016-17 as part of it's drive to strictly enforce drug regulations in the state.
The regulators have also taken cases against 65 pharmacy owners for selling drugs without the supervision of pharmacists.
In the last fiscal, prosecution for manufacture of spurious drugs stood as three, whereas, a total of 471 cases have been filed against various violations in this year (2016-17). All the cases are now under trials. Last year, in 2015-16, the total cases filed against different violations were 460.
One of the major steps taken during this fiscal is the filing of cases against offences by pharmacy owners. Regulatory officers all over the state took cases against pharmacy stores for selling drugs without the supervision of pharmacists. A total of 65 cases have been filed for violation of Rule 65 (2) which mandates supervision of pharmacists while dispensing drugs, as per D&C Rules, said M Abdul Khader, director of the DC department.
Apart from violation of Rule 65(2), the drug regulators prosecuted pharmacies for non-maintenance of prescription register (violation of Rule 65(3)), selling drugs without issuing cash bills (violation of Rule 65(4)(3)) and selling drugs without prescription (violation of Rule 65(9) A.
The joint director at the drugs control department, K Sivabalan, has claimed that Tamil Nadu is the only state where the highest number of prosecutions is charged against erring manufacturing companies and pharmacy owners every year. He said in all other states, the total number of prosecutions in one year comes around 150 or less than 200. Whereas in Tami Nadu the total number goes beyond 400 every year, he said.
He said the number of cases initiated against sub-standard drugs (NSQ) during 2016-17 was 80, whereas it was 81 in the last fiscal. This year 15 cases have been filed against companies for giving misleading advertisements (DMROA), but in last year it was 31.
As penal action, the department has suspended 105 sales licences this year. Last year it suspended 98 sale licences. Several licences for product enforcement were cancelled.
As an advantage on the part of legal action, the joint director said the judicial first class magistrate court in Villupuram imposed a penalty of Rs. 180,000 on Ahmadabad based company, Delux Surgicals, in last year for manufacturing and selling iv set which had failed in sterility test.
Tamil Nadu DC department had received the prestigious award, ‘State with Best Enforcement of Drugs Laws’ in May 2015 from the New Delhi based national NGO, Partnership for Safe Medicines (PSM) India Initiative. The award is given every year to a state drugs control department for strict enforcement of D&C Act and Rules.