Trace and track to ensure export of quality drugs
Updated: Jun 03, 2013 03:52:44pm
New Delhi, June 3 (KNN) The government today urged pharmaceutical companies in India to follow strict production and supplies procedures to ensure that drugs exported from the country are on par with global standards.
The new rules come in the wake of some top Indian pharmaceutical companies running into problems over their quality of products in the US, a major market for the domestic generic drugs.
The trace and track mandate has been implemented by the government in the pharmaceutical sector to enable monitoring of the supply chain at secondary and tertiary levels to safeguard export of quality drugs.
“The trace and track technology mandate at tertiary and secondary level stands implemented,” said an official statement by the Ministry of commerce and industry here.
The government and industry are working on a ‘trace and track’ mechanism which would enable monitoring of the supply chain possible at all the three levels- primary, secondary and tertiary.
Further, the date of primary level packaging has been postponed until July 1, 2014.
The department of commerce is currently in talks with the health department, seeking a common approach for both exports and domestic tracking.
Significantly, all concerned organizations in the government are constantly interacting to ensure that India’s image remains as a safe exporter from all angles.
The pharmaceutical sector is a highly regulated one and the exports are heavily guided by various regulatory regimes of the importing countries and there is also a requirement for continuous monitoring of quality related aspects including complaints of sub-standard and falsified drugs from various countries.
The government has to strictly meet international requirements for exports of pharmaceutical products by complying with the new procedural guidelines of the European Union (EU) for import of active pharmaceutical ingredients (APIs) into the country.
Moreover, companies and importers from all over the globe are encouraged to visit the manufacturing facility in India to satisfy themselves of the quality of production of drugs, the notification said.
Meanwhile, India has exported USD 14,590 million worth of drugs in 2012-13, which is more than its previous year’s export of USD 13, 165 million.
Indian exports of pharmaceutical products are fourth in the world in terms of production volumes, 13th in domestic consumption and 12th in terms of export value of bulk actives and dosage forms.
Over 55 per cent of Indian drugs are exported to highly regulated markets and USA is the largest export destination followed by UK.
According to a report by Pharmexcil, India had filed over 3000 drug master filings (DMFs) with USA amounting to almost 40 per cent of the total DMF’s filed with the Food and Drug Administration (FDA or USFDA). These have been filed by over 233 different companies from India in 2012. Out of these, 27 per cent of the formulations are exported to USA and India has a share of 15 per cent of US generics by way of volume. (KNN)
The new rules come in the wake of some top Indian pharmaceutical companies running into problems over their quality of products in the US, a major market for the domestic generic drugs.
The trace and track mandate has been implemented by the government in the pharmaceutical sector to enable monitoring of the supply chain at secondary and tertiary levels to safeguard export of quality drugs.
“The trace and track technology mandate at tertiary and secondary level stands implemented,” said an official statement by the Ministry of commerce and industry here.
The government and industry are working on a ‘trace and track’ mechanism which would enable monitoring of the supply chain possible at all the three levels- primary, secondary and tertiary.
Further, the date of primary level packaging has been postponed until July 1, 2014.
The department of commerce is currently in talks with the health department, seeking a common approach for both exports and domestic tracking.
Significantly, all concerned organizations in the government are constantly interacting to ensure that India’s image remains as a safe exporter from all angles.
The pharmaceutical sector is a highly regulated one and the exports are heavily guided by various regulatory regimes of the importing countries and there is also a requirement for continuous monitoring of quality related aspects including complaints of sub-standard and falsified drugs from various countries.
The government has to strictly meet international requirements for exports of pharmaceutical products by complying with the new procedural guidelines of the European Union (EU) for import of active pharmaceutical ingredients (APIs) into the country.
Moreover, companies and importers from all over the globe are encouraged to visit the manufacturing facility in India to satisfy themselves of the quality of production of drugs, the notification said.
Meanwhile, India has exported USD 14,590 million worth of drugs in 2012-13, which is more than its previous year’s export of USD 13, 165 million.
Indian exports of pharmaceutical products are fourth in the world in terms of production volumes, 13th in domestic consumption and 12th in terms of export value of bulk actives and dosage forms.
Over 55 per cent of Indian drugs are exported to highly regulated markets and USA is the largest export destination followed by UK.
According to a report by Pharmexcil, India had filed over 3000 drug master filings (DMFs) with USA amounting to almost 40 per cent of the total DMF’s filed with the Food and Drug Administration (FDA or USFDA). These have been filed by over 233 different companies from India in 2012. Out of these, 27 per cent of the formulations are exported to USA and India has a share of 15 per cent of US generics by way of volume. (KNN)
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