GMPs may take toll on drug exports
In what could hit the country’s vaccine exports estimated to be at Rs 1,500 crore, besides maligning the reputation of Indian companies, WHO is considering dropping India from its list of recommended countries to source vaccines.
By Khomba Singh, TNN |
NEW DELHI: In what could hit the country’s vaccine exports estimated to be at Rs 1,500 crore, besides maligning the reputation of Indian companies, the World Health Organization (WHO) is considering dropping India from its list of recommended countries to source vaccines.
WHO has found “problems with India’s drug regulator and some Indian pharma companies during a recent inspection” over the implementation of the prescribed standards of the good manufacturing practices (GMP) and it wants the government to cancel the GMP license of few state owned-companies , which the government is allegedly reluctant to do.
It is learnt from sources close to the development that the WHO recently inspected some GMP-approved units of both private and public companies in India. The agency was not satisfied with what it saw and has siad so in its report, which has been submitted to the health ministry a couple of months earlier.
According to some industry officials, the agency has asked the drug regulator to cancel the GMP licence of a couple of state-owned vaccine makers as they were not complying with the prescribed standards.
If WHO indeed delist the country, exports of leading vaccine makers in the country such as Panacea Biotec, Serum Institute of India, Shantha Biotec, Bharat Serum and Vaccines could be affected.
According to sources, some of the public sector units which are allegedly not adhering to the prescribed GMP standards include Pasteur Institute of India, Coonoor (Tamil Nadu) and Bharat Immunological & Biological Corporation. But this could not be independently confirmed.
When contacted, drug controller general of India (DCGI) M Venkateshwarlu said, “I have no comments to make.” WHO International office in Geneva did not reply to an e-mail sent by ET. WHO officials in India and senior officials of the health ministry, whom this newspaper spoke to, also declined comment.
A top executive of a leading vaccine maker said, “The WHO has given the Indian drug regulators time till December to cancel the GMP licence of a couple of public sector units. However the government is reluctant to delist the state-owned companies which are anyways not exporting much.” In India, the GMP standards approval are given by the state drug regulators and the DCGI.
Unlike other drugs which are more focused on retail market, vaccines are mostly sourced by governments and institutions in bulk. According to another pharma official, Indian vaccine makers export around Rs 1,500 every year, a large amount of which are sourced by global agencies such as WHO, UN and governments of several countries.
In the past, the WHO had dropped Indonesia for about a year over not proper implementation of GMP standards in the country.
WHO has found “problems with India’s drug regulator and some Indian pharma companies during a recent inspection” over the implementation of the prescribed standards of the good manufacturing practices (GMP) and it wants the government to cancel the GMP license of few state owned-companies , which the government is allegedly reluctant to do.
It is learnt from sources close to the development that the WHO recently inspected some GMP-approved units of both private and public companies in India. The agency was not satisfied with what it saw and has siad so in its report, which has been submitted to the health ministry a couple of months earlier.
According to some industry officials, the agency has asked the drug regulator to cancel the GMP licence of a couple of state-owned vaccine makers as they were not complying with the prescribed standards.
If WHO indeed delist the country, exports of leading vaccine makers in the country such as Panacea Biotec, Serum Institute of India, Shantha Biotec, Bharat Serum and Vaccines could be affected.
According to sources, some of the public sector units which are allegedly not adhering to the prescribed GMP standards include Pasteur Institute of India, Coonoor (Tamil Nadu) and Bharat Immunological & Biological Corporation. But this could not be independently confirmed.
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When contacted, drug controller general of India (DCGI) M Venkateshwarlu said, “I have no comments to make.” WHO International office in Geneva did not reply to an e-mail sent by ET. WHO officials in India and senior officials of the health ministry, whom this newspaper spoke to, also declined comment.
A top executive of a leading vaccine maker said, “The WHO has given the Indian drug regulators time till December to cancel the GMP licence of a couple of public sector units. However the government is reluctant to delist the state-owned companies which are anyways not exporting much.” In India, the GMP standards approval are given by the state drug regulators and the DCGI.
Unlike other drugs which are more focused on retail market, vaccines are mostly sourced by governments and institutions in bulk. According to another pharma official, Indian vaccine makers export around Rs 1,500 every year, a large amount of which are sourced by global agencies such as WHO, UN and governments of several countries.
In the past, the WHO had dropped Indonesia for about a year over not proper implementation of GMP standards in the country.
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