The Gujarat Food & Drugs Control Administration has withdrawn the product licenses of four of the banned drugs that were being manufactured in the state as a follow up of DCGI's decision. H G Koshia, commissioner of the Guj FDCA informed that he had sent the order on February 18 to all the manufacturers in the state soon after the meeting was concluded at the DCGI's office.
On February 15, Dr Surinder Singh had called an emergency meeting of Drugs Consultative Committee (DCC) to inform about banning of six controversial drugs nimesulide, sibutrimine, R sibutrimine, cisapride, decongestant drug phenylpropanolamine (PPA) and human placenta extracts.
A source observed that it was high time that these drugs were banned in India. He noted that it is surprising that these drugs were available in India this long even while they have been banned in most of the countries due to adverse reactions due to its medication.
Koshia informed that after receiving the notification the Guj FDCA has canceled 2188 product licenses of nimesulide, 1082 product licenses of PPA, 36 product licenses of cisapride and 90 product licenses of sibutrimine. He informed that no product license was ever issued for the manufacturing R sibutrimine and human placenta extracts in Gujarat.
According to Koshia this decision was taken by the DCGI after getting a cumulative report by the DCC, expert committee and doctors over the safety concerns on administrating these drugs. These drugs are banned under section 26A of Drugs and Cosmetic Act, following the studies revealing the potential of serious side effects like heart attacks, strokes and cardiac arrest etc.