In a surprise raid conducted all over the state, the drug control sleuths of Tamil Nadu have seized huge quantities of emergency contraceptive, ‘My Pal’ from Madurai and Chennai zones for violation of Schedule H of Drugs and Cosmetics Act. The drug was manufactured and marketed by Pfizer India, Mumbai.
Apart from case of misbranded drug, the department has initiated action against violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955, said a senior officer in the department.
This is the first time in last 10 years that the regulatory machinery in Chennai has taken action against a multinational company for violation of drugs and cosmetics act, the official said.
According to the official, the strip of the Pill does not contain the label indicating warning, manufacturing license no, batch no, date of manufacturing, date of expiry, contents, storage requirements..etc. But company’s address is there, he added by telling that all Schedule H drugs should bear a ‘Warning’.
“We have verified the label, there is no mark of Schedule H. More raids and seizures will be held in the coming days,” the officer told Pharmabiz.
The company’s website gives the information that the product can be used within 72 hours of unprotected intercourse to prevent an unplanned pregnancy and is most effective when taken within 12 to 24 hours of unprotected intercourse.
When contacted the higher officials of the department, they said earlier similar cases had been taken against contraceptives like ‘I-Pill’, ‘EK Pill’ etc.
With regard to DMROA violation, sources said that 26 such cases have been taken against allopathy and Ayurveda manufacturing companies across the state during last month. Out of this, three cases have been filed, sanction for initiating case proceedings has been given for three cases and investigation is going on for 20 cases. The drug official said some big companies of popular products are also under scanner.