Pharma exports to EU must comply with stricter rule
Updated: May 23, 2013 06:23:34pm
New Delhi, May 23 (KNN) Exporters of pharmaceutical products to the European Union (EU) will now require a written confirmation from the Indian government stating that the bulk generic drug has been manufactured in accordance with EU good manufacturing practice (GMP) standards.
“The new EU legislation coming into force from July-2 requires a ‘written confirmation’ by a competent authority nominated by the Government of India that the API has been manufactured in accordance with EU-GMP standards,” an official statement said today.
The facility where the active pharmaceutical ingredients (API) is manufactured would be subject to control and enforcement of GMP standards, equivalent to those in the EU countries.
APIs are commonly referred to as bulk drugs in the pharmaceutical industry and are used in the making of medicines.
The Central Drugs Standard Control Organization (CDSCO) has laid some guidelines-for issue of ‘written confirmation’ for APIs of medicinal products for human use, to be made by the exporter in a prescribed format.
A time frame of 45 days has been prescribed for disposal of satisfactory applications and the written confirmation shall be valid for three years.
Also, the European Union had issued a new directive in 2011 amending the previous one. The objective was to lay down a community code relating to medicinal products for human use and to ensure that the defective products do not reach consumers.
Moreover, the directive lays down a system of control over the entire supply chain for pharmaceuticals. It controls manufacture and import to marketing, wholesale and retail distribution.
EU is an important market for the pharma industry. During the period 2012-13 (April-January), the value of exports of drugs, pharmaceuticals and chemicals registered a growth of 7.33 per cent. (KNN)
“The new EU legislation coming into force from July-2 requires a ‘written confirmation’ by a competent authority nominated by the Government of India that the API has been manufactured in accordance with EU-GMP standards,” an official statement said today.
The facility where the active pharmaceutical ingredients (API) is manufactured would be subject to control and enforcement of GMP standards, equivalent to those in the EU countries.
APIs are commonly referred to as bulk drugs in the pharmaceutical industry and are used in the making of medicines.
The Central Drugs Standard Control Organization (CDSCO) has laid some guidelines-for issue of ‘written confirmation’ for APIs of medicinal products for human use, to be made by the exporter in a prescribed format.
A time frame of 45 days has been prescribed for disposal of satisfactory applications and the written confirmation shall be valid for three years.
Also, the European Union had issued a new directive in 2011 amending the previous one. The objective was to lay down a community code relating to medicinal products for human use and to ensure that the defective products do not reach consumers.
Moreover, the directive lays down a system of control over the entire supply chain for pharmaceuticals. It controls manufacture and import to marketing, wholesale and retail distribution.
EU is an important market for the pharma industry. During the period 2012-13 (April-January), the value of exports of drugs, pharmaceuticals and chemicals registered a growth of 7.33 per cent. (KNN)
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