Spurious drug menace unearthed
By Our Reporter
SHILLONG: The sorry state of affairs in the State Health Department came to light on Friday with the detection of preparation and supply of spurious medicines for infants.
On receipt of information regarding illegal and unhygienic manufacture of medicines at the industrial unit of Induscreed Pharmaceuticals situated at the Industrial Estate at Lawmali, the Civil Society Women’s Organization (CSWO) carried out an inspection where they discovered the same and found out from an assistant drugs controller, D Swer, that the license which was issued earlier to the company was cancelled in 2003 due to alleged malpractices.
There are reports that the company did not adhere to the laid down norms and conditions regarding the manufacture of medicines like Albendazole Suspension (de-worming medicine), Paracetamol (mild analgesic), liver tonic, furazolidone oral suspension (antibiotic used to treat infectious diarrhea) and Povidone Iodine Solution (stable chemical complex of povidone and elemental iodine possessing anti-bacterial activity. It is generally used for determining the skin pre and post operatively for all surgical procedures and for the antiseptic treatment of superficial wounds, burns and injuries). CSWO president Agnes Kharshiing, after carrying out an inspection at the industry site, told reporters on Friday that the officer, D Swer, was under pressure from the Government to revoke the cancellation but he stuck to his duty for the sake of the people.
According to Kharshiing, the official confirmed that the medicines manufactured by Induscreed were not as per the prescribed standards after a test was conducted in this regard.
“We found out that the medicines are being supplied to government-run hospitals including, Shillong Civil Hospital, Ganesh Das Hospital, PHCs and CHCs in rural areas,” Kharshiing said.
Earlier, the Medical Superintendent of Ganesh Das Hospital, in a letter dated October 4, 2012, had asked for a clarification from DHS (MI), on the quality of Albendazole Suspension supplied from the central store of Director of Health Services (MI) procured from Induscreed Pharmaceuticals.
According to the Medical Superintendent, as per the IP (Indian Pharmacopoeia), “the standard strength of Albendazole suspension is supposed to be 400mg for 10ml. But the medicine being supplied was found to be having 200mg for 10ml which is far below the standard set by the IP for Albendazole suspension”.
The CSWO leader stressed on the severe health hazards that may come about if Induscreed was allowed to supply the illegal and unhygienic medicines to the Health department.
“We feel that there can be a connivance of some officials from the Health and Excise departments in facilitating the supply of spurious medicines to kill our children,” Kharshiing alleged.
Induscreed Pharmaceuticals has also got the nod from the Excise department to import methyl alcohol for manufacturing chemicals. The CSWO alleged that there is a suspicion regarding the use of methyl alcohol.
Citing the CAG report for the year ended March 31, 2009, Kharshiing said that the test check of records revealed that a commercial firm located at Shillong imported 28,000 bulk litres of spirit, 24,000 bulk litres of absolute alcohol and 4,000 bulk litres of methylated spirit in four consignments between April 28, 2006 and May 27, 2008 on which import fee of Rs 1.92 lakh, though realizable, was not realised by the Department although the rules do not permit such exemptions.
The CAG report for the year ended March 31, 2010 further stated that during test check of the records in May 2009 it was found that the commercial firm imported 2,667 cases of absolute alcohol between October 2007 and February 2009 for use in manufacture of drugs and medicine. For import of the spirit, two import permits were issued without realization of import pass fee. Since import pass fee is exempted for the purpose of import of denatured spirit only, the grant of exemption was irregular; and resulted in loss of revenue of Rs 2.88 lakh, the CAG observed.
However, the CAG did not mention the name of the company in its reports.
As per norms, each licensee should have Good Manufacturing Practices (GMP) to manufacture medicines. The Schedule M of GMP states that each licensee has to evolve appropriate methodology, systems and procedures which will be documented and maintained for inspection and the manufacturing premises will be used exclusively for production of drugs.
“Since the medicines are meant to improve the health of all sections of people, we think that the High Court will take a sou moto action regarding the case,” Kharshiing said, adding that CSWO will continue to pursue the matter.
Kharshiing also asked the Government to shut down Induscreed immediately.
The CSWO also raised concerns on the delay in the appointment for the post of DHS (MI).
“The Government is playing with the life of the people especially children and it is unfortunate that the Government did not take into confidence experienced doctors as most of the procurement was made at the whims and fancies of certain officials,” Kharshiing added.