Case Summary: Eligibility Criteria in Drug Regulatory Positions

In a significant judgment by the Supreme Court of India, the criteria for eligibility in drug regulatory positions was clarified. The case addressed the qualifications necessary for roles such as Assistant Commissioner (Drugs) and Drug Inspectors. Explore how the Court examined the distinction between essential qualifications and desirable preferences in the pharmaceutical industry.

Facts

  • The respondents, who are Post Graduates in Pharmacy with over three years of experience in research and development, are deemed eligible for the position of Assistant Commissioner (Drugs) and Drug Inspectors.
  • The definition of manufacturing process in the Drugs and Cosmetics Act, 1961 was referred to in support of this eligibility.
  • The research work conducted in reputable laboratories is considered as part of drug manufacturing purposes.
  • No other grounds were presented by either party in relation to the eligibility of the respondents.
  • The High Court orders in favor of the eligibility of candidates with research and development experience for the specified positions were the subject of the appeal by the appellants.
  • The High Court reversed the Tribunal’s conclusion regarding the eligibility of candidates with research experience in synthesis and testing of drugs in a laboratory.
  • The High Court emphasized that such candidates should not be denied opportunities based on a misinterpretation of eligibility conditions.
  • Candidates with research experience were recommended by a Committee for consideration after document scrutiny.
  • Once permitted to participate in the selection process, these candidates could not be deemed ineligible.
  • The Tribunal and High Court distinguished between experience in manufacturing/testing in a research lab and the specific experience required for the recruitment.
  • Experience in a research lab only provided a preference and did not substitute the essential eligibility criteria.

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Arguments

  • Academic qualifications and practical experience in drug manufacturing and testing were deemed essential for appointment.
  • Research experience in a research and development laboratory was considered a desirable qualification, but not at par with the essential eligibility criteria.
  • Preference may have been given to candidates with research experience, but it could not replace the essential qualifications required for the appointment.

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Analysis

  • Section 3(f) of the Act defines ‘manufacture’ in relation to drugs or cosmetics
  • Qualifications for Assistant Commissioner (Drugs) include a degree in Pharmacy or Pharmaceutical Chemistry, experience in manufacture or testing of drugs, and enforcement of Act for a minimum of five years
  • Preference may be given to candidates with a postgraduate degree or research experience in synthesis and testing of drugs
  • Essential qualifications for appointment are at the discretion of the employer
  • Qualifications for Drug Inspectors include a degree in Pharmacy
  • Employer to decide on essential qualifications for appointment
  • The court cannot lay down the conditions of eligibility or reinterpret the advertisement and rules if they are clear.
  • Ambiguity in the advertisement or contradiction with rules/law must be referred back to the appointing authority for appropriate action.
  • Employers have the right to determine additional or desirable qualifications, including granting preference.
  • Judicial review does not extend to determining equivalence or suitability of qualifications.
  • Experience in testing must be related to the manufacturing process, not just research and development.
  • Preference in the advertisement implies additional weightage for higher qualifications.
  • Expert committee review does not override clear terms of the advertisement.
  • It is essential to meet the stated minimum qualifications in the advertisement for eligibility.
  • Candidates with additional desirable qualifications may receive preference, not automatic selection based on those alone.
  • The High Court’s interpretation of the advertisement terms regarding the posts of Assistant Commissioner (Drugs) and Drug Inspectors was deemed unsustainable and had to be reversed.
  • The High Court erred in concluding that a higher qualified individual like a M.D.S. qualified person was automatically entitled to be selected and appointed based on the preference for higher qualifications mentioned in the advertisement.
  • The advertisement’s preference for higher qualified individuals did not equate to an automatic selection and appointment of such individuals.
  • The High Court’s decision was incorrect as it did not consider that preference for higher qualifications did not guarantee selection.

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Decision

  • Orders of the High Court dated 04.05.2017 and 17.07.2017 are set aside.
  • No order as to costs shall be passed.
  • Appeals are allowed.

Case Title: MAHARASHTRA PUBLIC SERVICE COMMISSION Vs. SANDEEP SHRIRAM WARADE

Case Number: C.A. No.-004597-004597 / 2019

Click here to read/download original judgement

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