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Maha FDA cancels licenses of 2 wholesalers of Cipla for non-compliance of Drugs and Cosmetics Rules

Shardul Nautiyal, MumbaiMonday, January 16, 2017, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) has canceled licenses of two Nashik-based firms which procured drugs meant for hospitals by producing fake documents in contravention to the provisions of Drugs & Cosmetic Act, 1940.

In the latest breakthrough, the state regulator has found that medical representatives of Cipla company connived with wholesalers in forging bills and procuring medicines at discounted rates twice. These medicines were then stocked and supplied elsewhere when the stocks were actually meant to be supplied to hospitals.

Maharashtra FDA took action on the basis of procuring drugs without proper purchase documents under Section 18(c), 18(a)(vi) read with Rule 65(5) of D&C Act and rules thereunder.

The state regulator has filed FIRs against the accused wholesalers and the police has taken up the case under relevant sections of IPC. Based on the investigation, it was revealed  that the firm faked purchase invoices illegally in connivance with wholesalers, medical representatives and stocked it in medical stores.

Violations of D&C Act 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.

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.

Stop sale notices were earlier issued while the state regulator made surprise checks at 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.

Licenses of 500 retail pharmacies were cancelled 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.

 
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