Institute of Good Manufacturing Practices India
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Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
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Affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC)

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Certification programme to tighten the quality standards in its domestic drug industry

CDSCO has taken initiative to upgrade the skills of employees working in pharmaceutical and biologic manufacturing in order to bring great improvement in the quality of pharmaceutical products. The deadline set by CDSCO for completion of certification programme by all personnel in companies is 1st Jan 2018.

According to CDSCO, “no person shall be employed in any pharmaceutical/ biopharmaceutical manufacturing units unless he has obtained a formal diploma or degree in the relevant area or has been certified”. The step has been taken due to a number of regulatory actions which happened as a result of deviations from Good Manufacturing Practices as well as issuance of warning letters, product recalls and bans on import of drugs into the US.

The actions affected facilities manufacturing both finished dosage forms and APIs which were held for deficiencies such as compromised sterility, data integrity issues and inadequate cleaning, testing and complaint handling etc. This all has led to slow growth of India in the international trade in pharmaceuticals as India manufactures almost 30-40% of the generic medicines prescribed in the US market. The certification scheme comes on the back of other initiatives such as the introduction of a traceability system for exported medicines.



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