In order to deter the pharmacists from non-compliance to the Drugs and Cosmetics Act (D&C Act), Maharashtra Food and Drug Administration (FDA) has referred around 203 such cases to the Maharashtra State Pharmacy Council (MSPC) last year for further action in addition to 10 cases in 2014.  MSPC is a quasi-judicial body which can take actions ranging from issuing warning letters to cancelling registration of pharmacists based on the gravity of the case.     

The state FDA informed that 10 such cases of offending pharmacists referred to the MSPC for action this year relate to their absence due to renting out their certificates to the drug store and seeking employment elsewhere. MSPC on the other hand faces the challenge of timely and judicious disposal of such cases based on the merits of the case notwithstanding the fact that such cases have a bearing on the patient safety and need to be severely dealt with.

According to an official, mere absence of a pharmacist during an FDA inspection does not amount to a professional misconduct. That is why, each case takes several months to get resolved by the state council which calls the aggrieved party for explanation, hearing, defense, written submission till final ratification at the Executive Committee meeting held twice a year based on the merits of the case. A total of nine registrations have been canceled till 2013 and 134 cases are under process. Around 81 cases were referred between 2005 and 2010.  

MSPC can take actions against the pharmacists as per the Pharmacy Act under Section 36 wherein the Executive Committee can give the judgment based on the inspection report filed by FDA, oath of affidavit and explanation by the pharmacist.

As per FDA records, three pharmacists from Mumbai, two from Nanded, one from Pinjar, two from Thane and two from Nashik were booked under section 416 for impersonation, 420 for cheating and 199 for violating the affidavit of oath (false statement made in any declaration which is by law receivable as evidence).

Says Sanjay Kale, joint vigilance commissioner, FDA, "The state FDA has referred 10 such cases this year to MSPC for further action like cancellation of registrations under relevant sections of Pharmacy Act."

The State FDA has come across rampant violation of D&C Act last year as several chemist shops in the state despite their licenses being cancelled were found to be operating and dispensing drugs without a pharmacist. Around 2500 licenses have been canceled along with 1400 suspensions across Maharashtra by the state FDA over a period of seven months due to absence of pharmacists at drug counters.

"Referral of cases to MSPC is also required because we found that suspensions and cancellations have failed to make any impact as the drug store owners succeed in getting a stay on the matter from the appellate authority and continue running stores without a pharmacist," informs Kale.