At a time when the government is facing criticism on supply of spurious drugs by J&K Medical Supplies Corporation Limited (J&KMSCL) to state hospitals, the central drug authority has called for a more vigilant approach from state authorities for tacking the menace of substandard drugs while stressing on stricter adherence to the guidelines laid down by it for punitive action against violators.
“Although overall scenario of drug quality is improving in states, including J&K but there is need for concerted efforts to have zero tolerance to quality compromises from the state drug authorities,” K L Sharma, Joint Secretary Ministry of Health and Family Welfare, told Greater Kashmir. Sharma is heading the National Drug Survey 2016.
“There is a need to implement scientific statistical approaches and comprehensive sampling in addition to better infrastructure in J&K and all other states, he said. Though he said the drug regulatory system in the states had “already improved” but there was a need for “further improvement”.
Sharma said that the National Drug Survey 2016 could be adopted as a model to frame policies at the state level. “We ensured that 40 percent of the samples sent for testing were from rural areas, including those villages where not even a vehicle would go,” he said. Highlighting the importance of strict coding in samples to rule out any interference with testing, he said that “coding” was the cardinal measure of any quality control.
Pointing out the infrastructural deficiencies in states, the Central Drugs Standard Control Organization had recently written to all states, including J&K, that “stern action” against violators and “concerted efforts” from drug authorities were needed to “plug the gaps”. The CDSCO is also learnt to have directed J&K and other states to adhere to the guidelines for initiating action against violators to ensure stricter compliance to Drugs and Cosmetics Act.
The CDCSO has also called for steps to “improve the skill and knowledge of the regulators and the Drug Analysts” and a fillip to the infrastructure of state regulatory systems. “We are considering proposals from various states to improve the infrastructure for drug testing,” a CDSCO report stated recently.
In a meeting held recently, the CDSCO had stated, “Many states are presently not able to equip their laboratories with the latest equipment and facilities for some reasons.” The officials had pressed upon the state drug control officials to expedite the process to “avail the services of the Central Drug testing laboratories for testing of samples drawn by their inspectors”.
The state drug testing has come under discussion recently since six samples of the JKMSCL were reported to be substandard by Drug Controller. As per official records of Drug and Food Control Organization (DFCO), 2339 drug samples were lifted from Jammu and Kashmir divisions since April 2016 to December 2016. Of these, 46 drug samples were declared to be "Not of Standard Quality". The samples, as per DFCO were tested at the two Drug Laboratories in state, one at Patoli, Jammu, and the other at Dalgate Srinagar. In addition, a few samples had been sent outside the state for tests, officials said.
The drug controller’s office further stated that among the 46 samples, 22 were declared as misbranded having labeling errors and “minor defects” in packaging etc while 24 others failed in other parameters such as Assay content, Disintegration and Dissolution.
The Drug Controllers office said that of the total 2339 samples, 480 were samples from JKMSCL supply. “We have lifted 480 samples from JKMSCL supply and test results of 275 samples are yet awaited,” officials in DFCO said.
They further said that 299 samples were found to be of standard quality and the remaining six samples had failed tests on various parameters including Assay tests and tests on particulate matter (for injectibles).