Hundreds of API suppliers with plants in new Indian state Telangana need to update EDQM

By Gareth Macdonald contact

- Last updated on GMT

EDQM calls on Telangana based suppliers to update CEP details
EDQM calls on Telangana based suppliers to update CEP details

Related tags: Andhra pradesh, India

As many as 450 API and intermediate suppliers in India's newest State - Telangana – need to log their changed addresses with the EDQM before August.

The India Government created Telangana in 2014, separating it from Andhra Pradesh in response to decades of protests​ about economic, cultural and political division.

This week the European Directorate for the Quality of Medicines & HealthCare (EDQM) said creation of the new State has had an impact on its Certificates of Suitability (CEPs) programme, which suppliers use to show that drug substances comply with European Pharmacopoeia specs.

According to the EDQM, some facility addresses in current CEPs and pending applications that are listed as being in Andhra Pradesh may now be in Telangana.

A spokeswoman told in-Pharmatechnologist.com that: “It is the responsibility of CEP holders and CEP applicants to ensure that their CEPs, including addresses, are up to date."​ 

She added that: “It is equally important for the EDQM that information contained in CEPs accurately reflects the location of sites and that there are no discrepancies in the addresses reported for the same location."​ 

August deadline

Currently over 450 CEPs include addresses in the Indian state of Andhra Pradesh and many of these may be affected by the change.

The spokeswoman said “since this creation of this Telangana, the EDQM has received questions from CEP holders on what actions they should take to handle a change of address."​ 

She added that: “CEPs holders, whose address is located in the new state, are expected to update their CEP applications by 31 August 2015​.”

In the past the EDQM has suggested technologies like Google Earth​ could be used to precisely locate manufacturing facilities. The US search giant has already updated its map system to include India's 29th State.

Telangana 

When the plan to set up Telangana was confirmed in 2009​, many observers suggested the change would impact the drug industry as Andhra Pradesh was a major source of APIs and excipients used in the production of pharmaceuticals.

Speaking at the time M Narayana Reddy, former president of the country’s Bulk Drug Manufacturers Association (BDMA), told the Press Trust of India (PTI) active pharmaceutical ingredients (APIs) and intermediates worth around INR4bn (€58m) are produced in the region.

He also said that protests about the new State had interrupted production, citing a temporary manufacturing stoppage GSK in Rajahmundry and Eisai's decision to postpone the opening of a facility in nearby Vizag as examples.

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