Unauthorised Vitamin A capsules for crores of children!:Daily Sun

  The Vitamin-A capsules the government had been feeding the children twice a year has not been registered as a medicine in Bangladesh, which, as per the rules, makes the use and distribution of the supplement unauthorised in the country. The government has been distributing Vitamin-A capsules to 20 lakh children twice a year across the country to reduce the risk of child death and preventing blin
dness due to malnutrition. The Health and Family Welfare Ministry purchases the capsule with World Bank’s fund from several countries. The government has been distributing Vitamin-A capsules among the children initially with support from the UNICEF and later from its own fund since the 70s. In 2012, the government distributed some 10 crore piece Vitamins-A capsules among the children across the country without conduction any clinical trial. This capsule is also an approved supplement to be used in Bangladesh. According to the law of the land, it is necessary to get a prior approval from the Directorate General of Drug Administration before distributing or using any medicine in the country. It has been learnt that no approval has been taken for the Vitamin-A capsule that crores of children have been taking every year across the country. Meanwhile, the Health Directorate has once again taken initiative to collect 6.35 crore piece Vitamin-A capsules. The government will soon launch a Vitamin-A capsule programme using those Vitamin-A softgels across the country. Dr Md Shahnewaj, Director, National Nutritional Services of Health Directorate, told Kaler Kontho, “Vitamin-A is not a medicine directly, so there is no need for any prior approval from the Health Directorate.” However, Brig Gen Golam Rosul, Director of CMSD (Central Medical Storage Department) told this correspondent, “Of course, it will require registration. There will be no acceptability of Vitamin-A capsule without approval from the Directorate General of Drug Administration. This is the rule.” Prof Dr ABM Faruk, an expert of the Drug Control Committee and a teacher at the Institute of Medicine Technology of DU told Kaler Kontho, “The natural Vitamin-A that people consume through normal diet cannot be treated as medicine, but when a Vitamin-A capsule is taken orally or by any other means—it must be treated as a medicine. Use of such medicine will require clinical trial or prior approval from the Directorate General of Drug Administration.” Health Directorate sources said ignoring the rules, the health ministry earlier purchased 10 crore piece Vitamin-A capsules in 2012. The High Court issued a rule against the government over the issue. Besides, as per the rules, nobody is allowed to import medicines of a generic if more than three local companies manufacture and market the drugs of the same generic. Currently, five local pharmaceuticals companies are manufacturing Vitamin-A capsules and they have got approval for marketing and distributing the medicine, which makes it illogical for the government to import a huge amount of Vitamin-A capsules from abroad. CMSD sources said, “The government has been collecting Vitamin-A capsule from a Canadian company since long. But for the first time in 2012, government gave permission to an Indian company to supply the Vitamin-A capsule. The government in 2011-12 fiscal took a move to import 10 crore pieces of Vitamin-A capsule under the HPNSDP programme. Golam Rasul, Director, CMSD said, “We will not accept any medicines those are not registered with the Directorate General of Drug Administration.” Several sources of CMSD said many foreign companies are trying to supply Vitamin-A capsule defying the rules. Dr Md Shahnewaj, Director, National Nutrition Services said, “We will call a meeting very soon to fix the date for Vitamin-A campaign.” When asked about collecting Vitamin-A capsule without registration, Selim Barami, Director of Drug Administration said, “Considering the emergency national programme, we usually issue a no-objection certificate for the Vitamin-A capsule, but we have been advising for registering the medicine. Vitamin-A capsule belongs to a group of medicines, so it needs registration.” Courtesy: Kaler Kantho