The Drug Control Organisation of Jammu and Kashmir is not equipped to carry out many cardinal tests on drugs, and the results of the drug tests it is able to do are kept away from public eye, risking the life and health of people who could be consuming these.
Since March 2014, JK DCO has made no attempt to make masses aware about the drugs that have failed quality and integrity tests at the drug testing laboratory in Srinagar. While the last report of sub-standard drug list is of the year 2013-14 on the department’s official website; the officials avoid queries related to sub-standard drugs and direct the inquirer to their website.
The website has no updated content related to fake and sub-standard drugs. When asked for the details of the drugs that had been tested in the recent past and had not passed the quality tests, the officials dodged queries for a fortnight on one pretext or the other.
Nazir Ahmed Wani, Controller Drugs J&K said, “There is nothing that should ring alarm bells. It (report) is within the normal range.” Asked about the list of drugs that had been given the red card, he said, the test reports were at Srinagar lab and could be seen there.
At Srinagar Drug Testing Lab, it was learnt that the department had no sub-standard drugs’ list compilation. Some drug test reports that were available at Drug Testing Laboratory Srinagar and that the DCO agreed to give access to revealed that 17 drugs had failed on various parameters since March 2015 till November 2015.
Apart from the Srinagar lab, drugs are routinely being tested at two other labs, one in Jammu and the other in Chandigarh.
At Srinagar lab, out of the 930 samples tested, 17 samples failed the quality tests.
However, there is very little that the lab can test for. The lab is not equipped to detect microbial contamination in drugs. Sterility status of drugs given the ‘OK’ certificate is ambiguous.
At the Srinagar lab, the employees said that they are in the process of setting up the microbial laboratory. “We are in the final stages of setting up the microbial lab,” Drug Analyst Kashmir, Rifat, said.
Injections, IV fluids and other drugs which can prove fatal if there is a microbial contamination are not being screened for this parameter in Srinagar. “The drug inspectors send samples of injections and IV fluids to outside labs, if they feel something is wrong,” said the Drug Analyst.
When asked which injections and parenterals had failed in the sterility tests, she said that all such information was available at Drug Controller Office.
However, sources revealed that drug inspectors find it difficult to get costly injections and other drugs sent for tests to outside labs. A source revealed that DCO discourages Drug Inspectors from lifting costly drug samples as it is mandatory to pick four samples of each drug that is being sent for testing. “They tell them not to indulge in over-spending,” the source revealed further adding that budget constraints make it difficult to lift costly drug samples for tests.
DCO said that quality of drugs available had improved since the past few years. “In 2013-14, 80 drugs had failed tests. And last year, only 24 drugs failed tests,” said Controller Drugs. The weak infrastructure, and what seems to be optimistic attitude towards the presence of fake and sub-standard medicines in market, is adding to the chances of such drugs reaching consumers.
Stakeholders and doctors have been demanding increasing stringency on drug testing in J&K. Government has in past promised several measures including strengthening of labs, setting up a lab at Lakhanpur entry point and increasing the manpower of DCO.
However, going by a written reply given by Union Health Minister JP Nadda in Lok Sabha, 4.4% drugs were found to be sub-standard in the past few years. The Union Minister had informed Lok Sabha that 9092 out of 205448 drugs tested sub-standard.
Nadda also informed of the various steps that were being taken to strengthen vigilance on drugs and ensure people’s access to quality medicines.
As per a report (Shepherd M. Vulnerable points in the U.S. drug-distribution system 2004-13), Russia, China, India, Brazil, Mexico, Pakistan, Southeast Asian and Middle Eastern countries are considered as the chief operators in distribution and manufacturing of counterfeit drugs.
In another report, ‘Outsourcing Pharma – Worrying trends,’ it has been declared by the European Commission that 75% of the global cases of sub-standard and fake medicines originate from India.
