Rajasthan government's Free Drug Distribution Scheme has taken a beating with the incident of gross medical negligence at Jaipur based Government MDM Hospital where around 155 Pepenum injections were allegedly administered to 28 patients although on the label of injections it was clearly marked "Not for Human Use & For Animal Treatment only" for treating high bacterial infection.
According to officials, the prescribed quantity of veterinary medicine packs come with the picture of either a dog or a cow, essentially in pursuance of the Drugs and Cosmetics Act. But, Pepenum, did not have any such mark on label. On June 14, the hospital received from the market 1,000 such vials containing the drug, Meropenem, manufactured by Pushkar Pharma. Two days later the vials were sent to drug distribution centres (DDCs).
Meropenem is available in dosages of 500 mg and 1 gm and the quantity mentioned on the vials was 1 gm. According to an official associated with the development, "Administering of the drug is based on the weight and age of the patient. Scrutiny relates to the fact that why the drug was wrongly labelled 'For Animal Use'. The drug is tested based on the quality parameters of Indian pharmacopeia and the manufacturer has to take care of this aspect."
No adverse reaction has been reported till date and an inquiry has been initiated by the state government to find out how the injections reached the hospital drug store and whether the drug administered was correct. Each vial costs around Rs 350 in the market. The remaining 845 vials have been seized by the state drug control department.
The offence, however, according to experts can attract penalty on account of wrong labeling under the provisions of Rule 97 of the Drugs and Cosmetics Act, 1940. The manufacturer can face actions ranging from suspension and cancelation of license to withdrawal of product permission. The sample have been sent for analysis to the state drug testing lab at Jaipur which might take over a month's time.
Meropenem, considered a life-saving antibiotic drug, is administered to patients with high infection that is not treatable by any other drug. It is an ultra-broad-spectrum injectable antibiotic used to treat a wide variety of infections in post-operative conditions. The hospital had obtained the vials from the open market through tenders since the government did not have adequate stock.
The scheme was initiated in October 2, 2011 to address issues like insufficient supply of drugs, shortage of doctors, para-medical staff and pharmacists mainly at the primary health centres in remote villages. Rajasthan has a total of 17,298 healthcare institutions including primary health centres (PHCs), community health centres (CHCs), sub centres and government hospitals.