CDSCO renews API firms' 'written confirmations' days after industry raises trade concerns

By Gareth Macdonald

- Last updated on GMT

iStock/daboost
iStock/daboost

Related tags European union

CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.

The Indian Central Drugs Standard Control Organization (CDSCO) issued details of the firms it has issued with renewed written confirmations (WC) today​.

Publication of the list comes days after industry group Pharmexcil​ suggested CDSCO’s “lack of manpower​” could delay renewals and “hugely impact API exports to EU​.”

Pharmexcil said it asked the “CDSCO to issue the renewals on the basis of their current USFDA, MHRA,EDQM or CDSCO approvals and conduct the inspection later as and when inspectors would be available from the central and zonal offices​.”

“Written confirmation”

In 2011, the European Commission set out its rules on the importation of active pharmaceutical ingredients (API) in Directive 2011/62/EU​. The directive was part of a wider effort to ensure that fake and substandard ingredients do not enter the supply chain.

A central requirement was that API manufacturers outside the European Union (EU) would need to provide written confirmation their production sites meet with appropriate standards regardless of whether they have been inspected by the EDQM or by regulators from an EU member State.

API firms have needed to send these written confirmations with each batch shipped to Europe since July 2013.

The only exception is if the manufacturer in question is located​ in a country where standards have been deemed to be equivalent.

India

India was not granted this exemption, which meant that since 2013 CDSCO has had to inspect the manufacturing operations of companies seeking to tap the European market.

The first group of written confirmations which the agency issued to Indian API manufacturers in June 2013​ were due to expire this month.

An EMA spokesman told us the CDSCO is permitted to renew written confirmation documents without conducting new inspections, citing a European Commission questions and answer​ document published last year.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Related suppliers