Haryana pharma company linked to Gambia deaths was blacklisted by Vietnam
On December 24, 2013, the then consul general of India in Vietnam Deepak Mittal wrote to the Union health ministry regarding blacklisting of Indian pharmaceutical companies in Vietnam
: Maiden Pharmaceutical Ltd, having its manufacturing unit in Haryana’s Sonepat district and under scanner after it was linked to the deaths of 66 children in Gambia, was one of the 46 Indian companies blacklisted by the Vietnam government in 2013.
Four paediatric cough syrups manufactured by the company, which is based in Delhi, were lab tested and found to be of substandard quality by the World Health Organization (WHO).
WHO issued a medical product alert over the four cough syrups, warning they could be linked to acute kidney injuries and deaths of 66 children in Gambia.
As per a right to information reply of September 16, 2015 by Union ministry of health, Maiden Pharmaceutical was blacklisted by drug administration, Vietnam for quality violations during January 1, 2011 to October 10, 2013. The RTI was filed by Delhi lawyer Prashant Reddy.
On December 24, 2013, the then consul general of India in Vietnam Deepak Mittal wrote to the Union health ministry regarding blacklisting of Indian pharmaceutical companies in Vietnam.
“In view of the fact that a large number of Indian companies have been listed as defaulters by the Vietnamese authorities, it is requested that necessary background checks on these companies may kindly be undertaken in India to see if there are complaints against them from other countries and steps be initiated to penalise them for bringing bad name to the Indian pharma industries abroad,’’ Mittal wrote.
The then consul general also said that mission may be apprised of the action taken so as to reassure the local authorities of our commitment to continue to be reliable supplier of quality medicines.
However, whether any action was initiated against Maiden Pharmaceutical Limited either by the Drug Controller General of India (DCGI) or Haryana Food and Drugs Administration department is not known.
A 2014 note sent by Drugs and Food Quality Control (DFQC) section of Union health ministry to DCGI said that following a communication by the consul general of India to Vietnam, all zonal and sub zonal offices of Central Drugs Standard Control Organization (CDSCO) have been requested on February 6, 2014 to investigate the matter in respect of all exporters and manufacturers located in their respective zones immediately and take necessary action under intimation to DCGI.
On February 19, a note was again written proposing that DCGI may be asked to inform about the progress made so far because “we have not shown concrete results”. Again, a note was written in April 2014 by DFQC section to remind DCGI that an office memo of department of commerce pertaining to violations of quality control regulations and drug registration in Vietnam was referred to DCGI for comments, but comments have not been received so far.
State health officials said a countrywide survey on spurious drugs was conducted by the Central government in 2015 where samples from retail outlets were collected by teams of officials.
“Since Maiden Pharmaceutical medicines which were found of substandard quality by Vietnam drug administration were solely for export, those samples could never be collected during the 2015 survey,” said a health official in the know of things.
Kerala drug controller to initiate legal proceedings against company
Meanwhile, the Kerala drug controller’s office on Friday said they will initiate legal proceedings under the Drugs and Cosmetics Act against Maiden Pharmaceuticals since lab tests have confirmed serious discrepancies in the content of a drug - Maical D (calcium with vitamin D) manufactured by the company.
Hindustan Times had on October 6 exclusively reported that prescription drugs used to treat type-2 diabetes and an over-the-counter painkiller manufactured by Maiden Pharmaceuticals Ltd were found to be substandard during lab tests done by Kerala authorities on at least five occasions during the past nine months.
The drug controller confirmed that laboratory tests conducted on the Maiden Pharmaceutical manufactured Metformin and Easiprin found them of low quality while there were serious discrepancies in the content of another drug Maical D (calcium with vitamin D) manufactured by the company.
“We have also directed drug procurement agencies to stop purchase of all products of the said firm,” said Kerala Drug Controller PM Jayan.
He said in first two medicines – Metformin and Easiprin, the variation was minor and an explanation was being sought from the manufacturer, but in the third case, some contents (D3) claimed by the manufacturer were totally missing. He said tests were done after some doctors complained about the efficacy of these drugs.
“Though we do random testing, it is difficult to test all batches of medicine. When complaints surface, we test contents and other specifications minutely,” said Jayan, adding there were many complaints against the Maiden Pharmaceuticals in the last few months.