Alerts & Updates 17th Jul 2024
As the pharmaceutical laws become more stringent and compliance of such laws is brought under the strict radar of the authorities, the laws for this sector continue to evolve. In keeping with this, there have recently been two significant notifications by the government for this sector. Our update provides an overview of both these important developments.
On 10 July 2024, the Department of Health and Family Welfare notified the draft of the Drugs and Cosmetics (Compounding of Offences) Rules, 2023 (“Draft Rules”) and called for objections and suggestions on the same. The Draft Rules contain 7 rules for compounding of offences (whereby in lieu of undergoing prosecution and punishment, the accused can pay fine for the disposal of the prosecution) punishable under the Drugs and Cosmetics Act, 1940 (“the Act”).
Rule 3 of the Draft Rules provides the Central and the State Governments with the authority to appoint any person as compounding authority, for exercising powers and functions of the Central and the State Governments respectively.
The Draft Rules require that applications for compounding be made under Section 32-B of the Act. This section stipulates that any offence punishable under Section 13(1)(b), Section 28, and Section 28-A of the Act, provided these offences are not punishable solely by imprisonment or by imprisonment and a fine, can be compounded.
Under the Draft Rules, any company or other person may apply for compounding of offences either before or after institution of prosecution under the Act. The compounding authority will then call for a report and other relevant information from the authority within whose jurisdiction the offence has been committed and after consideration either allow or reject the application for compounding.
It is pertinent to note that under the draft rules, the applicant cannot claim compounding of the offence as a matter of right. Notably, an application for compounding will be adjudicated upon by the compounding authority and a reasoned order shall be passed in case of rejection of the application.
The Draft Rules provide the compounding authority with powers to grant immunity from prosecution for the offence under the Act, in cases which are covered by compounding of the offence. Where the application for compounding is allowed, the compounding authority shall indicate the compounding amount (as stipulated under the Act) and grant the applicant immunity upon being satisfied that the applicant has cooperated in the proceedings and has made full and true disclosure of facts relating to the case.
However, Rule 7 also provides the compounding authority with powers to withdraw the immunity provided, where such person fails to pay the compounding amount within 30 days from the receipt of the compounding order, or such person is found to have concealed any particulars, material or had given false evidence. In cases where immunity has been withdrawn, the person will be proceeded under the Act, as if no such immunity had been granted. In such cases, the accused is required to undergo the entire process of trial and if found guilty, may be sentenced to imprisonment prescribed under the Act.
| ELP Comments | |
| While compounding of offences was introduced in the Act way back in 2009, the Ministry of Health and Family Welfare has finally notified the rules for such compounding. This development makes the process of adjudication and imposing penalties less cumbersome, as earlier the complaints would have to be filed before the jurisdictional Magistrate, thereby burdening the Courts. | |
It was urged before the Drug Consultative Committee (“DCC”) in its meeting held in June 2023, that there is no clear indication of composition of excipients on strips of medicines. More importantly, this may cause inconvenience to patients who are allergic to excipients such as parabens. This issue was deliberated upon and in the next meeting held in September 2023, the DCC recomm
ended that sub-rule 7 of Rule 96 (the provision prescribing the manner of labelling of pharmaceutical drugs) should be amended for capturing the requisite details of the excipients in the QR code.
The Ministry of Health and Family Welfare, pursuant to the above recommendation of the committee, published the draft Rules vide notification dated 12 July 2024, in order to amend the Sub-Rule 7 of Rule 96 of the Drugs Rules, 1945 (“the Rules”).
Rule 96 of the Rules was amended to add sub-rules 6 and 7 vide notification dated 17 November 2022. By way of sub-rule 6, the manufacturers of drug formulations specified in Schedule H2 (prescription drugs) are required to print or affix a Bar Code or Quick Response (QR) Code on its primary packaging label that store data or information legible with software application to facilitate authentication. Sub-Rule 7 mentions the particulars required to be made available on such Bar Code or QR Code. The information that are required to be made available in bar code or QR Code include the unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacturing, date of expiry and manufacturing licence number.
Apart from the above particulars, the amendment proposes addition of “details of excipients” to be also made available on the Bar Code or QR Code. This addition is with the intention of making the end consumer/patient of the drugs aware of the excipients used in the manufacturing of the drugs for any hypersensitivities or allergies towards such excipients.
| ELP Comments | |
| The amendment to Rule 96 also comes in at a time where consumers/patients are conscious about the awareness of the products, particularly the ones that are consumed. This amendment will help understand any allergies that may be caused due to excipients and may assist the doctors diagnose the allergy induced health issues in their early stages. | |
We trust you will find this an interesting read. For any queries or comments on this update, please feel free to contact us at insights@elp-in.com or write to our authors:
Ashishchandra Rao, Partner, Email – ashishchandrarao@elp-in.com
Vinuta Rayadurg, Principal Associate, Email – vinutarayadurg@elp-in.com
