The legislature of all the Provinces enacted the Drugs & Cosmetics Act, 1940 (“the Code”) the principal legislation, “to regulate the import, manufacture, distribution and sale of drugs and cosmetics” for the whole of India. The Code provided the position of Inspectors for the said purpose, whose conditions to qualify for the appointment were to be made as per the Rules framed by the Central Government. Section 33 of the principal legislation, empowered the Central Government to make rules to compliment the principal legislation.

In exercise of the power under the said provision, the Central Government enacted the Drugs and Cosmetics Rules, 1945 (“Statutory Rules, 1945”) though through separate legislation, but a substantive legislation. Its Rule 49 prescribes the qualifications for the appointment of Inspectors. For a ready-reference the provision is re-produced ad-verbatim as follows:

[49. Qualifications of Inspectors. – A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law:
Provided that only those Inspector
(i) Who have not less than 18 months ‘experience in the manufacture of at least one of the substances specified in Schedule C, or
(ii) Who have not less than 18 months‘experience in testing of at least one of the substances in Schedule C in a laboratory approved for this purpose by the licensing authority, or
(iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspectors;
shall be authorized to inspect the manufacture of the substances mentioned in Schedule C:]

Additionally, the Recruitment Authority (“the Employer”) can, however, further draft rules or policies for the efficient recruitment of candidates. Thus, the Ministry of Health and Family Welfare framed the Central Drugs Standard Control Organization (Drug Inspectors) Recruitment Rules, 2010 (“Recruitment Rules/Subordinate legislation”) under the proviso of Article 309 of the Constitution of India, 1950 vide G.S.R. 86 E, Notification dated 19.02.2010.  However, the Recruitment Rules or the subordinate legislation was contrary to the quoted Rule 49 of the Statutory Rules, 1945. The Recruitment Rules omitted the above-noted phrases, i.e. “Provided that only those Inspector” and “shall be authorized to inspect the manufacture of the substances mentioned in Schedule C”.

As an effect of this, the Recruitment Rules mandated the experience as a pre-requisite qualification for the appointment of Inspectors under the Code. However, as may be noted, Rule 49 does not mandate experience as a pre-requisite qualification for the appointment of Inspectors. Instead, the pre-requisite of experience is for an inspector who subsequent to the appointment are employed to inspect the Schedule C drugs. The Statutory Rules, 1945 mandated only educational qualification and experience was only pre-requisite to inspect the Schedule C drugs, and not otherwise. Contrarily, the Recruitment Rules mandated experience regardless of the fact, whether he is assigned any other work or is assigned to inspect the Schedule C drugs.

Thus, the question, whether mandating of experience as a pre-requisite qualification for the appointment of an Inspector in terms of Recruitment Rules, 2010, when Rule 49 of the Statutory Rules, 1945 do not mandate, is ultra vires has been raised on several occasions before different High Courts. More pointedly, the question is can subordinate legislation impose an additional condition than provided under the statutory rules, for the appointment of an inspector under the principal Act?

Recently, the question came up before the Delhi High Court in U.P.S.C. v. Nidhi Pandey [Writ Petition (C) 2475 of 2019] (“Nidhi Pandey”).

In this writ petition, it is understood that the employer (the U.P.S.C) had issued an advertisement in terms of the Recruitment Rules mandating the requirement of experience as an essential qualification for the post of Inspector. Several candidates whose candidature was rejected by the employer for non-fulfilment of the condition of experience challenged the order before the Central Administrative Tribunal (“the Tribunal”) which decided in favour of the candidates. The employer challenged this order of the Tribunal in this writ petition.

The Petitioner contended that one, the Recruitment Rules were notified much after the Statutory Rules, 1945 and thus, would prevail. Two, the Petitioner placed reliance on the Official Liquidator v. Dayanand & P.U. Joshi (“Official Liquidator”) and contended that recruitment and qualifications and criteria of selection etc. fall within the exclusive domain of the employer. To pertinently quote, the Court had observed as follows:

“The creation and abolition of posts, formation and structuring/ restructuring of cadres, prescribing the source and mode of recruitment and qualifications and criteria of selection etc. are matters which fall within the exclusive domain of the employer. Although the decision of the employer to create or abolish posts or cadres or to prescribe the source or mode of recruitment and lay down the qualification etc. is not immune from judicial review, the Court will always be extremely cautious and circumspect in tinkering with the exercise of discretion by the employer. The Court cannot sit in appeal over the judgment of the employer and ordain that a particular post or number of posts be created or filled by a particular mode of recruitment. The power of judicial review can be exercised in such matters only if it is shown that the action of the employer is contrary to any constitutional or statutory provisions or is patently arbitrary or vitiated by malafides”. (para. 41).

Three, the requirement of experience is not in conflict with Rule 49 as only experienced persons can only serve the need of the employer. Last, the Petitioner relied on  Priyanka & Ors v. Union Public Service Commission (“Priyanka & Ors.”) wherein the Punjab & Haryana High Court had held that because the Recruitment Rules and the advertisement mandated experience as pre-requisite, and denial for lack thereof was valid (para. 6 & 7).

On the other hand, the Respondents contended that the Recruitment Rules could not have exceeded the essential qualifications stipulated in Rule 49. Rule 49 only mandated academic qualification as mandatory and the requirement of experience was a pre-requisite only to inspect the Schedule C drugs. The Respondents also averred that the facts of the present writ petition are squarely covered by the Kuldeep Singh and others v. State of U.P. and another (“Kuldeep Singh”) wherein the Allahabad High Court had held the mandate of experience as pre-requisite in Recruitment Rules and the advertisement issued by the employer as ultra vires.

The Delhi High Court pertinently first, noted that the Drugs & Cosmetics Act, 1940 and the Statutory Rules, 1945 drafted thereunder are central legislations, applicable to the whole of India (para. 14). Thus, the appointments were to be governed or regulated by the principal Act and Statutory Rules, 1945, drafted thereunder. Second, the Court observed that “when a Court interprets a statutory provision or a provision which is made by the delegate of the legislature while framing subordinate legislation, it must give effect to the plain, literal or grammatical meaning of the provision” (para. 16, Kuldeep Singh; para. 14, Nidhi Pandey).

However, such a plain and natural construction of Rule 49 does not infer experience as a pre-requisite qualification for the appointment of an Inspector. The substantive part of Rule 49 makes only academic qualification as a pre-requisite for the appointment of Inspectors. The proviso mandates experience as pre-requisite only for appointed Inspectors to inspect Schedule C drugs. Thus, the experience is not a pre-requisite to the appointment, rather it is to the inspection of the Schedule C drugs.

Three, the Court affirmatively quoted from Kuldeep Singh (supra) wherein the Court had observed:

Undoubtedly and as a matter of general principle, it is open to the appointing authority to prescribe the conditions of eligibility for the holding of a post. The conditions of eligibility may, in a given case, legitimately include the possession of an academic qualification and of experience even prior to appointment. But, once the field is governed by a rule which has been framed in exercise of a rule making power vested by statute, the statutory rules must govern” (para. 16).

Thus, when Rule 49 already provided the pre-requisite for the appointment of Inspectors, the Recruitment Rules could not mandate additional pre-requisite of experience for all appointments.

Last, the Court held that when Statutory Rules, 1945 does not prescribe a limitation, subordinate legislation cannot prescribe any additional condition or pre-requites. The only medium is to amend the statutory rules. Despite it, addressing the due need of the employer, “neither the State in its administrative capacity nor, for that matter, the Court would have the power to rewrite subordinate legislation [i.e. Drugs and Cosmetics Rules, 1945]”. (para. 26, Kuldeep Singh) Doing so, would amount to an amendment of the provision whose power is solely vested with the legislature.

Thus, in light of these reasons the Court concluded it untenable in law to mandate the experience as a pre-requisite under the Recruitment Rules when Rule 49 already provides for essential qualifications categorically. Giving an overriding effect to the subordinate regulation over the Statutory Rules, 1945 “is clearly impermissible in law” (para, 16, Nidhi Pandey).

The difference in the advertisements and the Recruitment Rules on the one hand and Rule 49, on the other hand, have been subjected to litigation on several occasions before.

For example, the Madras High Court had in the case of P.Elango v. The State of Tamil Nadu and V. Ilamaran v. The State of Tamil Nadu dealt with the issue of deletion of the requirement of experience in Recruitment Rules and advertisement. However, the Court appositely held that the experience is not a pre-requisite for appointments. The appointed Inspectors under Rule 49 perform “multifarious roles” one of which is to inspect the Schedule C drugs, subject to pre-requisite of experienceThus, the omission of experience was intra vires as no evidence on record showed that the employer called for appointments to inspect the Schedule C drugs right from the inception. But as may be noted, here there was no addition of a condition like in the present writ petition. The department had omitted to provide experience part in the advertisement made for the purpose of the appointment of Inspectors for purpose other than inspection of Schedule C drugs.

To pertinently note, the hint for similar consequences as in the present case can be not from the observance of the Court that the there is also no evidence from which it can be inferred that the appointments were made for the Inspectors to inspect the Schedule C drugs. Had this been shown, as per understanding of ratio in Nidhi Pandey, the Madras High Court may have held that the deletion of experience was ultra vires because this would have been contrary to the Statutory Rules, 1945 which prescribes the experience as pre-requisite for the inspection of Schedule C drugs.

However, as afore-noted, the identical issue determined by the Delhi High Court and Allahabad High Court has been contrarily determined by the Punjab and Haryana High Court (supra) in Priyanka and Ors. (supra). The Delhi High Court preferred the reasons of the Allahabad High Court wherein the Court exhaustively determined the issue contrary to the Punjab and Haryana High Court which briefly determined the issue.

The Delhi High Court has primarily placed the reliance on the principle that the primacy must be given to the words used by the legislature and an intent drawn therefrom by giving the words used their natural meaning. When the legislature provides for particular qualification(s) it is not open for the employer to make subordinate rules contrary to the statutory rules, whether by adding some condition or removing or altering the minimum condition i.e., altering educational qualifications. Thus, the employer has to engraft its recruitment policies within the stretch provided by the statutory rules. Such policies cannot be completely out of the judicial review as afore-noted by the Supreme Court in Official Liquidator (supra).

Until 05.04.2021, the issue had been dealt only by the afore-noted High Courts. On this date, the Hon’ble Supreme Court dismissed the special leave petition preferred by Director General, Central Drugs Standard Control Organisation and Ors., impugning the judgement of the Delhi High Court in Nidhi Pandey. Thus, by necessary implication it is now settled that recruitment rules could not have override the Drugs & Cosmetics Rules, 1945 and prescribed additional qualifications than as prescribed in the statute.