The offices of the assistant drugs controllers of Eranakulam and Kollam in Kerala have initiated legal and departmental actions against two ESI Hospitals in the state for violation of Rule 65 of the Drugs & Cosmetics Act.

While a case has been registered against the ESI Dispensary at Eranakulam, only a departmental action was taken against the ESI Hospital at Kollam

In Kollam, the drug control officials have not registered a case of violation under Rule 65 of the D&C Act even though they have seized date expired drugs from the stores and pharmacies of the ESI hospital. As per the office records, the time barred drugs were used for distribution to patients even after four months of their expiry, sources from Kollam ADC office said.

When asked why a case was not registered against the ESI hospital at Kollam, M Jyothi Kumar, the drug inspector who associated with the joint raid along with CBI officials last month, said a standing circular of Drugs Controller certifies that only departmental action could be initiated against those who violate the conditions of drug licence. ESI hospital at Kollam is a drug licensee. He said procedures to cancel the drug licence of the hospital are going on.

According to sources from the ADC office in Eranakulam, the ESI Dispensary has distributed expired drugs to the patients under treatment and it has no drug licence.

Sources from the drugs control department said even though, as per Schedule K, the hospitals are exempted from taking licences, recent verdict of Supreme Court specifies that all the hospitals should obtain drug licence for dispensing medicines.

The regulatory staff from the office had associated with the CBI officials to conduct joint raids in two ESI hospitals in Kerala, one being at Kollam, last month following reports that the hospitals were supplying sub-standard and expired drugs to patients.

Revi S Menon, the ADC of Eranakulam, told Pharmabiz that the drug inspectors have seized expired drugs from the dispensing store of the ESI Dispensary towards which its Pharmacy had supplied the drugs. Samples of all the four kinds of expired drugs collected from the dispensary have been sent to the state Drugs Testing Lab in Thiruvananthapuram for testing. The report is awaited.

'Eye Clean', an eye drop manufactured by Parenteral Drugs India Ltd Indore, Coversyl, a tablet for heart disease patients manufactured by Serdia Pharmaceuticals Mumbai, Cesaxil, a dry syrup manufactured by Lark Laboratories New Delhi and Microl, a sachet packet manufactured by Micron Pharmaceuticals Vapi in Gujarat are the products seized from the Dispensary. The ADC said the expiry date of Eye drops was passed in February this year, but it was found that the medicine was distributed till May. The other three medicines had also passed their expiry dates in January 2010, but were supplied till May.

In the CBI raid conducted simultaneously in Kollam, the drug officials there found two kinds of time barred drugs used for distribution to the patients. Drug Inspector C Suresh Babu said, as per the office records of the ESI Hospital at Asramam in Kollam the authorities in the hospital had distributed Astyfer Syrup and Neutrosec Syrup, two vitamin Tonics, manufactured by Chennai based Tablets India Pvt Ltd, and samples of the same have been sent for testing. The expiry date of the former was February 2009 and of the latter was July 2009. The drug Inspector who associated with the CBI officials for raid said the two drugs were distributed past their expiry dates.

On suspicion, the drug officials and CBI sleuths have taken samples of other eight medicines from the pharmacies of the hospital and sent for testing at the government lab in Thiruvananthapuram. Most of the drugs are antibiotic, anti diabetic and Antipyretic drugs.

Samples of Ecoglim-1, tablets manufactured by Afya Pharmaceuticals, Haridwar, Crasmic-MF, tablets produced by Windlas Biotech Ltd, Derradun, Paracetamol-Tab-IP from Bengal Chemical & Pharmaceuticals Kolkata, Glito-15, manufactured by Medley Pharmaceuticals Jammu, Nicopenta, tablet manufactured by Pro Laboratories Pvt Ltd, Haridwar, Amlomed-5, produced by Acme Formulations Pvt Ltd, Solan, Ciprofloxacin-Hydrochloride- Tab-IP, manufactured by Hindustan Antibiotics Ltd, Pune, and Ecap 400, manufactured by Glenmark Pharmaceuticals, Daman were taken for testing.

The CBI has conducted raids in the hospitals as part of their country-wide crackdown on spurious and expired drugs following reports of expired drug scam in Tamil Nadu.