The Hindu Business Line : Drug regulator to get more inspectors

Coming on board
By Oct 2009, 63 drug inspectors would be joining CDSCO after going through UPSC, taking total strength to 94
A new proposal has been mooted to add another 106 drug inspectors by the end of 2010

Thomas K. Thomas

New Delhi, July 17 The Drug Controller-General of India (DCGI) is planning to ramp up its manpower by adding about 170 drug inspectors to take their total number to 200.

The move follows the central drug regulator’s decision to withdraw the powers given to State-level regulators to issue export quality licence-technically called Certificate of Pharmaceutical Products (CoPP).

It is aimed at bringing regulations in the pharmaceutical sector more in line with guidelines issued by the World Health Organisation (WHO).

WHO recommends the issue of CoPP and Model Certificate of Good Manufacturing Practices for medicinal products exported to international markets.

The grant of these certificates was so far delegated to the State Licensing Authorities by the Central Drug Standard Control Organisation (CDSCO) in view of the shortage of manpower.

However, it has been observed that the certificates issued by the States are often at variation with the guidelines of the WHO Certification Scheme.

Even the prescribed formats are not adhered to.

WHO has also written to the office of DCGI objecting to giving the title of ‘WHO GMP Certificate’ by the State Licensing Authorities.

“For the purpose of issuance of CoPP certificate, it is expected by WHO that the national regulatory authority of a country — CDSCO in the case of India — has verified that medicinal products covered in the certificate are consistently produced by the firm and conform to the GMP and quality standards prescribed.

It is further observed that these certificates are being issued on the basis of interpretations, which vary from State to State.

Call for more

The availability of large variants of such certificates creates confusion in the minds of regulatory authorities of importing countries,” said a Government official.

While 63 drug inspectors would be joining CDSCO by October 2009 after going through the process of selection through the UPSC taking the total strength to 94, a new proposal has been mooted to add another 106 drug inspectors by the end of 2010.

“The Central Government would therefore, be having enough manpower to handle the responsibility and grant CoPP as per WHO norms and fulfil the international obligation effectively,” the official said.

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