The Kerala Drugs Control Department has issued stop-sale order to Biomirrah Biogenics Ltd based at Kozhikodu, the marketing company for the product ‘Feromera’, a syrup manufactured by MMC Healthcare, Solan in Himachal Pradesh.
The state drugs controller C S Satheesh Kumar said decayed worms and ants were found in one of the bottles of the syrup sold to a consumer at Kozhikodu last week. The enforcement officials have seized the drug and sent samples to the government drug testing laboratory at Thiruvananthapuram for testing.
He said 346 bottles of the drugs have been withdrawn from the market and stop sale notices were issued to the C&F agent and the distribution companies. All the chemists and druggists have been also asked not to sell the drug until further orders. The drugs controller said Feromera is an iron tonic manufactured by MMC Healthcare.
According to sources in the DC department, this is the third time Kerala enforcement authorities have initiated action against MMC Healthcare against various violations. In October last year, in a raid conducted by the officials of the assistant drug control office at Ernakulam seized three items of misbranded anti-inflammatory medicines, Septidase D, Septidase Forte and Septidase tablet, worth Rs.6 lakhs from a wholesale dealer. The drugs were manufactured by MMC Healthcare. Cases of violation of Rule 95 (ii) of the Drugs & Cosmetics Rules, 1945 against the wholesale dealer and the manufacturing company were taken after the raid. The sources said it was a banned pain killer and was manufactured by MMC Healthcare.
Secondly, in February this year, in a state-wide crackdown on wholesalers and retailers, the enforcement officials seized huge quantities of Septidase-D, manufactured by the same company, and registered cases against violation of Rule 26 A of the Drugs and Cosmetics Rules 1945. According to sources, despite prohibition, the company has been marketing the drug in Kerala for the last 22 years. The department registered 147 cases against the C&F agent, wholesalers and retailers after the seizure.
Whereas, in March this year, MMC Healthcare filed a writ petition before the high court of Kerala for the disposal of Exhibit P-14 (governmental action), following it the Court stayed the departmental action initiated against the company and its marketing agency.
Satheesh Kumar said the company’s three products, Septidase-D, Septidase Forte and Septidase Tablet, were misbranded under section 17 (b) of the D&C act 1940 read with rule 96 (iii) of the D&C Rule, 1945 and Septidase D was a banned combination. The DC informed the details to the Drugs Controller General of India (DCGI) and is waiting for his report for further action.