A big boost to drug discovery

In what can be a big boost to the drug discovery and development process in the country, the Union Health Ministry has recently issued a final notification amending the New Drugs and Clinical Trials (ND&CT) Rules 2019, to include provisions for deemed approval for various steps involved in the clinical trial for new drugs, including registration of ethics committees, conducting clinical trials and manufacturing new drugs for test or analysis or clinical trials. Undoubtedly, India is emerging as a major hub for clinical research as ND&CT Rules, 2019 has been able to offer clarity in guidelines for Indian clinical trial subjects to actively participate in new Covid-19 vaccine trials.

Besides, diverse patient population pool as compared to global patient population is also helping the country in witnessing development of clinical research. Clinical trials protocol has today become more streamlined with the coming up of ND&CT Rules, 2019 involving a lot of regulatory, economic, skill and subject enrollment interventions and protocols. ND&CT Rules 2019 are being fruitful in providing guidance on running clinical trials smoothly in accordance with approved protocol from ethics review boards and regulatory authorities. Now, the government has further amended the ND&CT Rules to make it more industry-friendly. The Ministry, on January 21, 2022, had published a draft notification, seeking the stakeholders to submit objections and suggestions and the objections and suggestions received from the public on the proposed amendment have been considered by the central government before finalising the notification.

As per the amended in the ND&CT Rules, in Rule 8, sub rule 3(ii), a provision has been inserted as per which if there is no communication received from the Central Licensing Authority (CLA), i.e the office of the Drugs Controller General of India, to the applicant within the 45 working days period, the registration of Ethics Committee shall be deemed to have been granted by the CLA and such registration shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trial in accordance with these rules.

The applicant who has taken deemed approval under this amended provision should, before initiating the functions of the Ethics Committee, inform the CLA in Form CT-02A and the CLA will, on the basis of this information, take on record the Form CT-02A which will become part of the official record and will be called deemed registration of the CLA. The next provision to be inserted is under Rule 22, Sub-Rule (2), wherein if there is no communication from the CLA to the applicant within the 90 working days period, the permission to conduct all clinical trial will be deemed to have been granted by the CLA and such permission shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trial in accordance with these rules. In Rule 24, a provision to be added under which if there is no communication from the CLA to the applicant within 90 working days period, the permission to conduct all clinical trials shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trials in accordance.

In yet another boost to drug discovery in the country, the government has made another amendment in Rule 34, Sub-Rule (2), as per which a provision is added that if no communication has been received from the CLA to the applicant within the 90 working days period, the permission to conduct bioavailability or bioequivalence (BA/BE) study of the new drug or investigational new drug shall be deemed to have been granted. A Sub-Rule, (2A) is proposed to be added so that the applicant who has taken deemed approval shall, before initiating BA/BE study of the new drug or investigational new drug, inform the CLA in Form CT-07A and the CLA shall on the basis of the said information take on record the Form which will become part of the official record and shall be called deemed approval of the CLA.

In Rule 53, in Sub-Rule (1) and (2), a provision will be inserted under which if no communication has been received from the CLA to the applicant within the period of 90 working days, the permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study or test and analysis shall be deemed to have been granted by the CLA and it shall be deemed to be legally valid for all purposes and the applicant shall be authorised to manufacture the new drug or investigational new drug for the said purpose, after submitting a Form CT-11A.

Similarly, under the Rule 60, Sub-Rule (1)(ii), if no communication has been received from the CLA to the applicant within the period, to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study shall be deemed to have been granted by the CLA and such permission shall be deemed to be legally valid for all purpose and the applicant shall be authorised to manufacture the new drug or investigational new drug for said purposes in accordance with these Rules. In Rule 60, the Sub-Rule (2)(ii) shall also be amended, stating that in case of rejection, the applicant may request the CLA to consider the application within a period of sixty days from the date of rejection of the application on payment of fee as specified in the sixth schedule and submission of required information and documents. Definitely, the Union Health Ministry's initiative will help fast-track the drug discovery and development process to the marketing stage in the country.

(The author is a freelance journalist with varied experience in different fields)