Maha FDA detects Mumbai based firm selling spurious drugs

Mumbai, September 2016

In its ongoing drive against illegal sale of medicines, the Maharashtra Food and Drug Administration (FDA) has seized stock of active pharmaceuticals ingredients (API) from a Mumbai-based firm which was selling drugs without proper purchase invoices and were also procuring spurious drugs in contravention to the provisions of Drugs & Cosmetic Act, 1940.

During investigation, it was found that the firm was holding one ton stock of antibacterial drug ciprofloxacin manufactured at Nanded and also vitamin E acetate manufactured in Mumbai without proper purchase invoices which was indicative of illegal purchase of drugs.

Stocks of drug worth Rs. 18 lakhs were seized from the godown at Bhiwandi in Thane district. It was also observed that the firm has procured purchase invoices from three firms, where only bills were issued.

Maharashtra FDA has taken action on the basis of misbranded drugs and drugs without proper purchase documents under Section 18(c), 18(a)(vi) read with Rule 65(5) of Drugs and Cosmetics Act, 1940 and rules thereunder.

Further investigation is in progress under the guidance of FDA Commissioner Dr Harshdeep Kamble and Joint Vigilance Commissioner Harish Baijal. 

Violations to Drugs and Cosmetics Act, 1940 have been rampant since the past six months relating to not having proper purchase and sale bill and absence of pharmacists in the drug retail stores across the city. Cases detected during surprise raids amounting to violation under D&C Act included even dispensing Schedule H drugs without prescription by unqualified people to the patients.

Licenses of 500 retail pharmacies were canceled and of another 1,674 retail drug stores were suspended as a part of inspections done on 18,067 retail pharmacies across the state between April 2015 and January 2016.

The state drug regulator in the past had also served 2,428 show cause notices on the retailers based on violations of D&C Act like dispensing medicines without prescription, without proper bill and for absence of pharmacists.

The state regulator had in the past cancelled eight licenses and suspended another 30 during the period between May 1, 2016 and May 23, 2016 for non-compliance to D&C Act. Out of the eight cancelled, six were retail licenses and two were wholesale licenses. Out of 30 suspended, 23 were retail licenses and 7 were wholesale licenses.

Stop sale notices were earlier issued while the state regulator made surprise checks at 11 such drug retail stores and found that pharmacists were absent in two of the stores of Mumbai region in violation of Rule 65(2) of the D&C Act which attracts penalty both under Pharmacy Act and Drugs and Cosmetics Act for professional misconduct. Pharmabiz