Dr Sanjay Agrawal Dr Agrawal
founded PHARMA CONSULT-ANTS and INVENTOR to fulfill his passion, capabilities and desire to assist pharmaceutical companies around the globe. He has actively worked in pharmaceutical and related industries for more than 28 years and started this firm in 2005. He is Editor-in-Chief of renowned IJM Today and honorable member of the editorial board of The Antiseptic.
A notice has been published by Ministry of Health and Family Welfare dated 16.01.2020, wherein draft recruitment rules for Drug Inspector (Medical De-vices), Assistant Drugs Controller (I) (Medical devices) & Deputy Drug Con-troller (I) (Medical devices) has been circulated in which Engineers and Bio-technologist were allowed to apply. Sur-prisingly Pharmacist has been given the last priority in specifying qualification. From time to time requirement has been raised to allow pharmacist to prescribe and medicate. The new notifi-cation has not only insulted the profes-sion of pharmacist but also proved that pharmacist are overlooked by the gov-ernment.
Recently the union health minis-try have appointed Drugs inspec-tor (around 23) and Assistant Drugs controllers (02 Numbers) who all are from mechanical engi-neering background. They do not have any knowledge of Human Anatomy, Human Physiology, Patho-physiology, Biochemistry, Pharmacolo-gy, Toxicology, Drugs Pharamcokinetics and Pharmacodynamics, Drugs Safety, Clinical studies, clinical performance, preclinical safety and toxicity studies, Quantitative Structure activity relation-ship of drugs, Medicinal chemistry, Im-purities, stability studies, process vali-dation studies, technology transfer, scale-up and post approval changes, Good manufacturing practices, good clinical practices, Pharmaceutical analy-sis, good laboratory practices and many such specific knowledge of drugs and devices. Engineering disciplines never have these subjects in their curriculum and hence they won‟t be able to under-stand the drugs actions, adverse effects, drug abuse and misuses etc. These people will not only make the drug regulatory process cumbersome but due to absence of pharmacy professionals the drugs regula-tions becomes handicapped. This will affect the lives of the citizens, we can‘t afford to allow these engi-neers to play with the health and lives of the people.
The draft recruitment rules are against the provisions of Drugs and Cosmetics Act, 1940 and Rules, thereunder.
- Rules 18 of the Medical Device Rules, 2017 gives provisions for designating the Medical Device testing officer and Medical Device officer. It does not give the power to appoint the said officers but gives power to designate such officers.
- Under Rule 18 (1) of the Medical De-vice Rules, 2017; the central govern-ment may designate a Government Analyst appointed under section 20 of the Act as Medical Device Testing officer.
- The Government Analyst under sec-tion 20 of the Drugs and Cosmetics Act, 1940 is appointed by the govern-ment in compliance to the Rule 44 of Drugs and Cosmetics Rules, 1945.
- Under Rule 18 (2) of the Medical De-vice Rules, 2017; the central govern-ment, or as the case may be, the state government, may designate an In-spector appointed under section 21 of the Act as Medical Device Officer.
An Inspector under section 21 of the Drugs and Cosmetics Act, 1940 is appoint-ed by the government in compliance to the Rule 49 of Drugs and Cosmetics Rules, 1945.
“Rule 49. Qualifications of Inspec-tors. —A person who is appointed as an Inspector under the act shall be a per-son who has a degree in Pharmacy or Pharmaceutical Sciences or Medi-cine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law: Provided that only those Inspectors:
i. Who have not less than 18 monthsexperience in the manufacture of at least one of the substances speci-fied in Schedule C, or
ii. Who have not less than 18 monthsexperience in testing of at least one of the substances in Sched-ule C in a laboratory ap-proved for this purpose by the li-censing authority, or
iii. Who have gained experienc-es of not less than three years in the inspection of firms manufactur-ing any of the substances speci-fied in Schedule C during the tenure of their services as Drugs Inspectors; shall be authorised to inspect the manufacture of the substances men-tioned in Schedule
From the Rule 49 it is clear that only a person who is appointed as an In-spector under the Act shall be a per-son who has a degree in Pharma-cy or Pharmaceutical Scienc-es or Medicine with specialisation in Clinical Pharmacology or Mi-crobiology from a University estab-lished in India by law. And such person who has been appointed under section 21 of the Drugs and Cosmetics Act, 1940 possessing the qualifications as per Rule 49, shall be designated by the central or state government, as the case may be to the post of Medical Device Officer.
Also, the post Drugs Inspector (medical devices) is nowhere mentioned in the Act or Rules thereunder. The prescribed quali-fications in the medical device rules have to be as per the provisions of The Drugs and Cosmetics Act, 1940 and Rules there-under. This makes the draft recruitment rules ultra vires and violates the provi-sions of Article 309 of the constitution of India.
By recruiting the persons with knowledge in Engineering does not serve the entire purpose of Medical Device Regulation which comprises the very diverse in na-ture. Due to the dynamic nature of Medi-cal Device field, the persons with the engi-neering background shall not be suitable for performing his duties.
The draft regulation is very partial deci-sion and not benefitting the society in any way. The author strongly believe that the said draft regulation shall be revoked and the pharmacist must not be behaved as step child.