HC directs re-testing of 156 drug samples at two labs

Fayaz Bukhari
SRINAGAR, Sept 10: The Jammu and Kashmir High Court today directed that all the drug samples taken after expose of spurious drug scam in the State in April this year be sent to two separate drug testing laboratories for re-testing and the results be matched.
The Division Bench of the Jammu and Kashmir High Court comprising Chief Justice MM Kumar and Justice DS Thakur directed that the 156 drug samples taken by Central Drugs Standard Control Organization (CDSCO) from hospitals and chemist shops in the State in April this year after expose of spurious drug scam be sent to two separate drug testing laboratories.
The CDSCO had taken 156 samples out of which 107 samples were sent to the Government Analyst Durgs Laboratory Chandigarh and 49 to Government Analyst Central Drugs Laboratory Kolkatta. Out of 107 only 7 were found sub-standard and out of 49, twenty were substandard.
The Court observed that there was huge difference in the results of the two testing laboratories as Chandigarh Laboratory has found 6.5 per cent drugs as substandard while Kolkatta laboratory has found 41 per cent drugs sent to it as substandard.
In order to clear the doubt, the court has directed that all 156 samples should be re-tested at two laboratories. The court has asked the Government to file the status report of these samples in 5 weeks. “And the pattern in future shall be followed by sending the samples to more than one laboratory”, the court directed.
It may be mentioned here that out of 156 samples sent to two testing laboratories, 27 drugs were found sub-standard.  The sub-standard drugs included  Dicloflam Injection IP, manufactured by M/s Ethicare Laboratories Jammu; Inu Amoxicillin and Potassium Clavulenate IP manufactured by M/s Karnataka Antibiotics and Pharmaceuticals Limited, Bangalore; P-Min10% manufactured by M/s Minil Laboratories, Industrial estate Jammu; Zepoxin Injection manufactured by M/s Neon Laboratories Ltd, Mumbai; TRAXOL (Ceftriaxone Injection IP) 1000 manufactured by M/s GMH Organics, Baddi District Solan, HP; NIMETH-Injection manufactured by M/s Nitin Laboratories Ltd, Karnal Punjab; BIOTOCIN-Injection manufactured by M/s E G Pharmaceuticals, District Solan, HP; Metonorm (Metoclopramide Injection IP) manufactured by M/s Ethicare Laboratories Jammu, Jammu; Dexamethasone Sodium Phosphate Injection manufactured by M/s SGS Pharmaceuticals Pvt Ltd Roorkee; Pheniramine Maleate Injection IP manufactured by M/s SGS Pharmaceuticals Pvt Ltd Roorkee; Diclofenace Sodium Injection manufactured by M/s Visa Drugs and Pharmaceuticals Pvt Ltd Gullar Walla, Baddi, Himachal Pradesh; Metonorm (Metoclapramide Injection IP) manufactured by M/s Ethicare Laboratories Jammu; Bolocef 250 Injection manufactured by M/s Bio Search Organics, Kathua Jammu; Metonorm (Metoclapramide Injection IP) manufactured by M/s Ethicare Laboratories Jammu; Cefotaxime Sodium Injection IP 500 mg manufactured by M/s Vivek Pharma Chem Ltd Jammu; Pheniramine Maleate Injection IP manufactured by M/s SGH Pharmaceuticals Pvt Ltd Roorkee; Curcef 1000 Injection manufactured by M/s RH Laboratories, Opposite Gondpur Industrail area, Poanta Sahib, HP; Cureclox (Amoxycillin Dicloxacillin capsules) manufacture by M/s Orison Pharmacetucals, 51 Industrial estate Ambala Cantt; Levocetirizine Dihydrochloride Tablets IP 5 mg ( Levitrax) manufacture by M/S Regency Health Care Rudra Pur Uttarakhand; Cefpodoxime Proxetil Tablets IP(Cefdom-p) manufacture by M/S Roseate Medicare Solan, HP; Calcium Carbonate tablets ( Marycal 500) manufacture by M/s A K Biotech Pvt Ltd Kartholi Jammu; Ofloxacin tablets IP ( ONOFBACT 200) manufactured by M/S Sea Pharmaceuticals Ponta Sahib; Nitrofuratone Tablets IP manufacture by M/s Martin and Harris Laboratories Haridwar and Cloazepam 1 mg IP manufacture by M/s Beta Drugs Nandpur Baddi.
The court has also directed the State to complete the formalities regarding the Government sanction for delinquent officials so that they can be prosecuted. The court has granted Government 4 weeks time for the sanction.
The status report filed by the Additional Sectary Health and Medical Education before the court reads:”..after receiving the report from the committee charge sheet served was upon the accused officers. A full-fledged departmental inquiry is in progress against the delinquent officials and enquiry is yet to be completed.”
The court observed: “We expect the department to allow the enquiry officer some reasonable time to complete the enquiry.”
A report by the CDSCO revealed that the joint investigations into the scam is going on by high level officers.
The Court asked the Advocate General M I Qadri about the action taken by the Government regarding sub-standard drugs. “Action has been taken and about 71 lakh tablets and injections were seized and manufacturing units have been closed and their license cancelled. The manufacturing of 27 drugs that were found substandard has been stopped”, Qadri told the HC.
The High Court also rejected the application of Dr Anis Chowdhry, the former Vice Chairperson of the Purchasing Committee, for making him party respondent in the PIL to defend his case.
The Court while rejecting his application observed that after charge sheet was filed against him before the trial court it would not be proper to accept this application. “He shall approach the trial court in this behalf”, directed the HC.
It may be mentioned here that Excelsior broke the spurious drug scam early April this year leading to registering of cases against suppliers and manufacturers of Maxamizine-625 drug that was supplied to hospitals across Kashmir valley. The antibiotic tested negative for amoxicillin while the company had claimed that it contains 500 miligramme of amoxicillin.
The drug, Maximizane 625 milligram, along with several other drugs were chosen in random sampling for laboratory testing by the Drug Controller Kashmir during winter. The drugs were sent to the laboratory for testing and the anti-biotic tested negative as the laboratory report revealed that it contains “NIL” Amoxicillin. The drug contained Zero milligrams of Amoxicillin tri-hydrate while the company claims that it contains 500 milligrams of Amoxicillin tri-hydrate + 125 milligrams clavulanic acid.
Following the expose and outcry across the State, the Union Health and Family Welfare Minister, Ghulam Nabi Azad sent an 11-member team from the CDSCO to the Jammu and Kashmir to investigate the quality of drugs being supplied to the Government run hospitals and those available in the open market.
A team of experts from CDSCO headed by Deputy Drug Controller (North Zone) Dr K Bangarurajan visited various hospitals of the State and collected samples of 156 drugs as part of the investigation ordered by the Union Health Ministry into the spurious drug scam.

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