In CWP No.5937 of 2018 (O&M)-PUNJ HC- Original or renewed licence to sell drugs is valid for five years from date of its issuance under Rule 63 of Drugs and Cosmetics Rules, 1945: P&H HC Justice Jaishree Thakur [25-04-2022]

Read Order: Tarsem Singh v. State of Punjab and others 

Monika Rahar

Chandigarh, April 30, 2022: Referring to Rule 63 of the Drugs and Cosmetics Rules, 1945,the Punjab and Haryana High Court has observed that an original licence or a renewed licence to sell drugs, is valid for a period of five years from the date on which it is granted and an application for renewal of licence in force is required to be made before its expiry or within six months of its expiry.

In brief, the facts of the case before the Bench of Justice Jaishree Thakur are that the petitioner, the sole proprietor of M/s Public Medical Store, was running the said medical store under the licences issued by the third respondent in January of 2004. In the year 2008, the petitioner could not apply for the renewal of his licence before its expiry, owing to his illness. 

As the term of the licence had expired, he applied for renewal of his licence, however, no action was on the said application. Thereafter, the petitioner submitted his representation in the form of an appeal, however, no action was taken on the same too. 

Thus, the petitioner, while claiming himself to be unemployed and devoid of another source of income, sought the issuance of directions from the High Court to the respondents to renew his licence by deciding on his representation. 

It was the case of the petitioner’s counsel that the respondents did not, intentionally, decide on the application submitted by the petitioner for renewal of his licence and subsequently, the representation was also left undecided. It was argued that the petitioner already deposited the requisite fee and complied with all other formalities as required for renewal of the licence. 

Per contra, the State Counsel argued that first of all the petitioner did not disclose the intention behind submitting his application for renewal of licence after more than 4 ½ years of expiry of his licence, because in 2013, the Drug Inspector on a surprise checking, seized 54 types of allopathic drugs in Form-16 from the unlicenced premises of the petitioner and on being asked, the petitioner could not produce any drug licence in respect of the premises or a valid registered medical practitioner certificate, so as to justify the stocking of huge quantity of allopathic drugs for the purpose of sale. 

It was submitted that because of the non-production of any valid licence to purchase/sell the seized allopathic drugs, a criminal complaint was already filed against the petitioner for contravening the provisions of Section 18(c) and 18-A, punishable under Section 27(b)(ii) and Section 28 of the Drugs and Cosmetics Act, 1940 in which charges were framed against the petitioner in 2016 and the same was still pending consideration. 

It was further argued that under Rule 63 of the Drugs and Cosmetics Rules, 1945, the petitioner was required to get the licences renewed either before the expiry of the said licences or within six months of its expiry together with an additional fee in Form 19 of the Drugs and Cosmetics Rules, 1945 whereas, he did not do so on or before the expiry of his licences in 2009.

At the very outset, the Court reiterated undisputed facts of the case which were that the drugs licences were issued to the petitioner in 2004 and the same were valid for a period of five years i.e. up to 2009, as per Rule 63 of the Drugs and Cosmetics Rules, 1945. Further, the court observed that as per Rule 63 of the Drugs and Cosmetics Rules, 1945, the petitioner was required to get the licences renewed either before the expiry of the said licences or within six months of its expiry together with an additional fee in Form 19 of the Drugs and Cosmetics Rules, 1945. 

Pertinently, the Court mentioned that during a surprise checking in 2013, 54 types of allopathic drugs were seized from his unlicenced shop by the then Drug Inspector and on asking, the petitioner could not produce any valid licence, to justify the stocking of a huge quantity of said allopathic drugs, leading to the filing of the criminal complaint. Further, the Court also noted that in the said proceedings pending before the Trial Court, the Registered Medical Practitioner (RMP) certificate produced by the petitioner, in order to avoid his criminal prosecution, was found to be false on verification. 

Also, the plea of the petitioner’s deteriorating health condition for not renewing his licence was not found to be plausible by the Court, in absence of production of any document in support of this plea. 

Lastly, the Court stated that Rule 63 of the Drugs and Cosmetics Rules, 1945, clearly provided that an original licence or a renewed licence to sell drugs, is to remain valid for a period of five years from the date on which it is granted and an application for renewal of licence in force is required to be made before its expiry or within six months of its expiry, otherwise, the licence is deemed to be expired.

In view of the above discussion, the Court held that no ground was made to issue any direction to the respondents to renew the licences of the petitioner. Hence, the petition was dismissed.