The office of Central Drugs Standard Control Organisation (CDSCO) may ask the Centre to increase the number of drug inspectors under it to 500 as the requirement of the regulatory staff will be much more with its increased responsibilities, according to Dr Surinder Singh, DCGI.
He was addressing IPA president’s national seminar on ‘Regulatory challenges-global pharmaceutical market’, organised by the Indian Pharmaceutical Association (IPA), in Hyderabad recently. The DCGI said that manpower is being increased substantially. There were only 12 drug inspectors with the Central Drugs Standard Control Organisation in 2008. Currently the CDSCO has 72 drug inspectors and the government has agreed to increase to it 150.
The DCGI is also in the process of creating state-of-the-art infrastructure across the country. The CDSCO, which already has its network in 9 states, is planning to expand its network into three more states. The DCGI is planning to delegate the power to approve drugs to zonal and sub-zonal centres. The authority to renew the licenses of blood banks will also be delegated to zonal and sub-zonal centres.
He said that in order to check the menace of spurious drugs, 2-D barcodes and Unique Identification (UID) will have to be introduced on the labels. “Consumers can know by SMS whether the drug is genuine or not. It is not going to be very expensive and it will cost only 35 paise. It will empower the consumers.”
Commenting on the inspections of overseas manufacturing facilities, DCGI said that the first team will go to China within 15 to 20 days. In the future, teams will be dispatched not only to China but to Italy, other European countries and US as is the case with US FDA and Medicines and Healthcare Products Regulatory Agency (MHRA) of UK.
Dismissing the reports that Indians are becoming guinea pigs in the clinical trials being carried out by multinational companies in India, he said that India hosts only 1.5 per cent of the trials are carried out across the globe. Countries such as the US and Canada have the highest number of trials and that’s why they are able to come up with new drugs, he said.
R P Meena IPS, director general, Drugs and Copy Rights, Andhra Pradesh Drug Control Administration asked the industry to find a solution for the huge fee required for registration of drugs in overseas countries as it’s a major problem for the small and medium companies. He urged the government to delegate powers to state drug controllers to issue licenses and regulate clinical trials.