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Guidelines for Inspection of GMP Compliance by Ayurveda, Siddha & Unani Drug Industry

Drugs and Cosmetics Act 1940 and Rules thereunder provide for appointment of Inspectors of Ayurveda, Siddha & Unani (ASU) systems of medicines who play significant role in implementation
of Drugs & Cosmetics (D&C) Act 1940 and Rules thereunder. One of the important tasks of Inspectors working under the State Licensing Authority of ASU systems is inspection of ASU Drug manufacturing Units before issuing license to manufacture ASU drugs under the provisions of the D&C Act and Rules thereunder.

Training level and experience of Inspectors for the purpose of regulatory implementation varies because qualifications prescribed for Drug Inspectors of ASU drugs vary. The Inspector may be a graduate in Pharmacy/ Pharmaceutical Chemistry/ Medicine (with specialization in Clinical pharmacology or Microbiology) having undergone practical training in the manufacture of ASU drugs or having a Degree/Diploma in A/S/U systems of medicines or possessing Degree in Ayurveda Pharmacy as per the provisions of the Act and Rules thereunder. Under such circumstances when the qualifications and experience levels of inspectors vary, it is important to impart comprehensive knowledge of the D&C Act and Rules thereunder to the inspectors for facilitating uniform implementation of the Act. This is all more important as there is no induction training when the person with requisite qualification is assigned the job of an inspector. In many of the States, due to lack of dedicated manpower for enforcement of provisions of Drugs & Cosmetics Act, ASU doctors working in the Hospitals/ Dispensaries are designated as inspectors usually without any additional capacity building training specifically on analytical aspects. In such a situation this manual becomes even more essential.

This inspection manual covering various aspects about the qualifications, duties and responsibilities of inspectors will be a much needed helpful guide for orientation of ASU inspectors for proper discharge of their duties under D&C Act and Rules thereunder. The Guidelines for Inspection of GMP compliance by ASU drug industry are especially explained in detail for development of insight of the inspectors regarding interpretation and implementation of the Rules. This manual is expected to assist State Licensing Authorities to augment the regulatory capacities of inspectors and develop master trainers as well.

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