New Delhi : The first nationwide survey of spurious and not-of-standard quality drugs in the domestic market, commenced by the Central government in 2014, is almost completed and will be submitted to the Health ministry by the end of this year.
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New Delhi : The first nationwide survey of spurious and not-of-standard quality drugs in the domestic market, commenced by the Central government in 2014, is almost completed and will be submitted to the Health ministry by the end of this year.
The survey is being carried out on the basis of 48,000 drug samples collected from different parts of the country by engaging almost 1000 drug inspectors. It covers 224 molecules of 15 major therapeutic drug groups relevant to Indian market. Indian Statistical Institute jointly with National Sample Survey Organisation had developed a unique statistical design for the purpose.
Central Drug Testing Labs in Chandigarh, Mumbai, Hyderabad, Chennai, Kolkata and Guwahati, state drugs testing labs in Gujarat, Karnataka Maharashtra and a lab of Indian Pharmacopoeia Commission are part of testing and analysis of the samples.
Looking at the number of officials, other staff and organizations involved in this major initiative, a clear picture of the extend of spurious drugs circulating in the Indian market should be available. As per the original plan, the survey was to be completed by February 2015 but was delayed on account of identifying specific geographical areas where spurious drugs are more available in the country.
Last all India survey of spurious drugs was conducted in 2009 but was not considered as a complete survey as the collection of samples was not extensive and elaborate giving no accurate picture of the problem.
Initial trends emerging from the nationwide survey on the basis of routine random- sampling exercises done over a period of one year reveals presence of sub-standard drugs in the domestic market has come down from 8 per cent to 4.5 per cent. That is certainly a relief to the domestic pharmaceutical industry which has been facing relentless accusations from the global regulatory authorities regarding the quality of drugs produced in the country.
The initial indications of the survey came at a time when 7 drug companies in India with substantial exposure to the US market, said that some of their manufacturing facility inspections in the past two months have reached successful closures, signaling resumption of supplies and new product filings to the US market.
The government’s initiative to conduct the nationwide survey of spurious drugs is in the context of attempts by certain vested interests to tarnish India’s image as a reliable exporter of cheap generics to the global markets. India’s emergence as a strong player in the global pharmaceutical market had been under attack for some time by spreading rumours that Indian drug makers also produce and export spurious drugs.
The survey is an attempt to disprove this false propaganda and bring out the facts and thereby strengthening the credibility of Indian pharma industry with scientific based evidence. Publication of the survey results in a few months from now should provide some support to the Indian pharmaceutical exporters in future.