In a big haul of cache, the Andhra Pradesh Drug Controller Authority (APDCA) has seized illegally manufactured drugs worth Rs.9 lakh and froze 50 kgs of 'codeine phosphate' (an addictive ingredient used in Cofcare syrup) from S K Healthcare Formulations Pvt Ltd here in Hyderabad.
Moving forward with the intention to crack down all those firms violating the laws and regulatory norms, R P Thakur, IPS, director general of APDCA, has initiated a special drive to investigate all those firms which have been illegally manufacturing, distributing and selling the drugs without a valid license and also without following the various provisions of drugs acts as they may have far reaching consequences in the public health.
According to official sources from APDCA, S K Healthcare has been manufacturing Cofcare and Bro-cofdex syrups along with New Okaril expectorant without having any license from the drug control authorities in the state. The Cofcare syrup is meant for treating patients suffering from cough while Bro-cofdex and New Okaril expectorant are anti-cold decongestants. Incidentally all the above three brands belong to Cipla Limited and are manufactured by S K Healhtcare and marketed by Cipla itself.
Upon conducting inspections, the officials found that the company S K Healthcare, which is located at Bachupally in Quthubullapur Mandal of Rangareddy district, is acting as a third party manufacturer for Cipla and the firm does not have any licenses for manufacturing these formulations.
The officials at DCA informed Pharmabiz that the company had grossly violated section 18(c) of Drugs and Cosmetics Act (D&C Act). In view of this the DCA is gearing up to take all necessary actions and book cases on all those involved in the illegal manufacturing and marketing of drugs.
Taking serious note of the issue, the APDCA had already issued notices to Cipla and S K Healthcare and had ordered a recall of entire stocks of drugs sold by them under their mutual marketing agreement.
“We have already issued show cause notices and booked cases against all those who had violated the rules and norms. Stern action will be taken against those who have illegally manufactured the drugs without taking any license from the DCA and sold without adhering to the conditions of license for sale,” informed R P Thakur, DG, APDCA.
Cipla, being an internationally reputed drug maker in the country, should have had minimum diligence to cross check or verify the manufacturing license of the S K Healthcare formulations. They have done a grave mistake by not verifying the firm’s license. They should take corrective steps at the earliest, otherwise law will take its own course, opined the DG.
Cofcare syrup contains an addictive substance called codeine phosphate and that falls under narcotic drug psychotropic substance list. Use of this substance in disproportionate ratio will have unsafe health repercussions in the patients and may become addictive to the drug. “Since the company had also violated the Narcotic Drug Regulations (NDPS) Act, we have informed Narcotic Control Bureau about this issue. Once we get a detailed report we will prosecute and charge sheet all those involved in this illegal business,” informed the DG.
Earlier the S K Healthcare had approached DCA for licence for New Okaril and Bro-Cofdex which does not have ‘No Objection Certificate’ (NOC) from Central Drugs Standard Control Organization (CDSCO) and the same was informed to the firm and rejected to issue the licence.
It is believed that the S K Healthcare had supplied huge consignments of these drugs to Kerala. Already the information regarding the illegal consignment of 20,000 bottles of Cofcare syrup sold directly by S K Healthcare to Medifort in Kozhikode through a distributor Chemsol Labs from Hyderabad was passed to Kerala Drugs Controller and drugs worth Rs.25 lakhs were seized by Kerala DCA officials last week.
The crack down initiative seems to be only a beginning, as most of the firms are unwary and taking things for granted, the State DCA officials are seriously investigating into complaints and taking all steps to book the fraudulent firms.
As more investigations are going on, the DCA officials are expecting few more firms to fall in line for the DCA’s whip for violating regulatory and legal norms.