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Indian pharmaceutical companies must also adapt to the changing landscape of regulations with an increased demand for timely regulatory approvals from CDSCO (Central Drugs Standard Control Organisation), as they face many obstacles in obtaining timely approvals for their products. The recent development of the SUGAM Portal and the NDCTR (New Drugs and Clinical Trials Rules) 2019 has created a need for Indian pharmaceutical companies to utilise structured, evidence-based methods to reduce the time between application submission and approval.
The following article provides step-by-step and animal-friendly methodology for how pharmaceutical companies can create a compliant strategic plan for shortening the approval process and increasing their ability to predict the outcome of regulatory approvals within the next five years.
1. Choose the Correct Regulatory Pathway at the Planning Stage
The chosen pathway is the most critical determinant of the time taken to approve a submission. Under the NDCTR 2019 and subsequent amendments, there are several ways that CDSCO allows submissions, including:
Standard Review
Accelerated Approval
Permission for Restricted Use in Emergency Situations
Waiver/Reduction of Local Clinical Trial Requirements
When submitting a scientifically valid request for both accelerated or conditional approvals for products aimed at the treatment of rare/neglected/unmet disease populations or serious conditions, the time required for review may be greatly shortened.
Before commencing Product Development, Companies should conduct a Pathway Assessment based on Global Regulatory Precedents, Epidemiological data, and Benefit-Risk Comparisons.
2. Conduct a Pre-Submission Meeting to Eliminate Uncertainties
As we approach 2025, pre-submission consultations with the Central Drug Standard Control Organisation (CDSCO) and with Subject Expert Committees (SECs) are becoming increasingly crucial to the success of drug submission applications. These consultations provide several benefits to applicants, including:
Validation of the clinical development plan
Establishment of local trial requirements or waivers
Clarification of the documentation requirements
Prevention of scientific or safety-related objections
To ensure that the results of these pre-submission consultations lead to a more efficient process for submission, it is critical to have an effective meeting agenda and to prepare a well-thought-out and structured briefing document with well-framed questions.
3. Submit a Technically Robust and Reviewer-Ready Dossier
Missing or poorly maintained documents often create delays with government approvals. By submitting complete electronic dossier (eDossier) documents that meet all requirements will help increase the speed and quality of the review process. Important contents of an eDossier include:
Clinical summary, non-clinical summary, and Pharmaceutical summary of the dossier.
Stability data and good manufacturing practice (GMP) documentation for the product.
Complete quality information on the active pharmaceutical ingredients (APIs) and final dosage forms.
All current certifications, site master files, and inspection report documents.
Reason for selecting comparators, dosing regimens, and endpoints.
India-specific labelling, prescribing and pharmacovigilance.
Building the eDossier documents using a logical format that meets eCTD requirements will provide faster internal access to CDSCO authorities and SEC members.
4. Leverage the SUGAM Portal Efficiently
The SUGAM platform serves as the central location where companies submit their applications for drugs, clinical trials, ethics committee registration, and manufacturing licenses. To ensure that applications are successfully processed, companies must:
Choose the correct application category for each submission.
Upload all mandatory forms and annexures.
Follow the size and format requirements set by the portal.
Track their application's status and any query notices in real time.
Submit the required fee receipts along with other supporting documents promptly.
To reduce their chances of having administrative rejections, which would result in application delays of several weeks, regulatory teams should receive periodic training on using SUGAM.
5. Use Global Regulatory Evidence to Seek Trial Waivers, When Justified
Applicants can request several options with respect to products approved by mature regulatory authorities (e.g. US FDA, EMA, MHRA, PMDA):
1. A bridging study instead of a full, local trial, or
2. A waiver from clinical trial requirements (where applicable).
Companies seeking these options must submit:
-relevant consolidated foreign data
-post-marketing surveillance (PMS)
-population data comparing the Indian patient population to the clinical population
-a benefit-risk assessment that is well structured.
The advantage of a well-supported waiver request is that it reduces the total burden to develop a product and reduces the CDSCO review cycle.
6. Prepare a Comprehensive Pharmacovigilance and Risk-Management Plan
The CDSCO is putting greater concentration on patients' safety by focusing more on post-marketing surveillance and has created a stronger pharmacovigilance (PV) structure by including:
1. The establishment of country-specific Pharmacovigilance Standard Operating Procedures (SOPs);
2. The appointment of adequately qualified pharmacovigilance officers (QPPVs);
3. The establishment of mechanisms for collecting adverse drug events/adverse drug reaction reports;
4. Commitments to produce periodic safety report (PSUR); and
5. Risk minimisation activities and plans for post-marketing studies.
Having a strong and credible PV programme increases the level of confidence and trust from regulators, which provides for an easier pathway to approval; the same holds for products that are being reviewed through accelerated/conditional pathways.
7. Strengthen Clinical Trial Execution and Data Quality
Launched Clinical Trial Local Approval Timeliness Will Be Dictated By :
Clinical Trial Site Initiation and Ethics Committee Approvals Timely
High-Quality Data Capture in Accordance with GCP
Agenda for Monitoring/auditing
Rapid Resolution of Protocol Deviations and/or Inconsistencies
The use of experienced Indian CROs and pre-qualified investigators will improve clinical trial execution speed and the integrity of data.
8. Prepare for SEC Meetings With Anticipatory Documentation
An evaluation from the SEC usually determines whether or not a company will advance in the application process or require additional questions. Therefore, companies must be able to provide:
A brief scientific presentation
Point-form responses to anticipated questions
Visual aids that illustrate the proof of efficacy and safety
Clarifications on trial methodologies or statistical analyses
Proposals for mitigation of risk
By providing clear and evidence-based communication, decision-making is improved and thus enhances the time efficiency of committee review.
9. Ensure Manufacturing and GMP Readiness Early
Being ready for CDSCO inspections is very important when applying for, creating or expanding an existing manufacturing facility. Companies need to have the following:
- A current Good Manufacturing Practice (GMP) Certificate
- A solid Quality Management System (QMS) is in place
- Batch Documentation and Corrective and Preventive Action (CAPA) records that can be traced
- Qualification and Validation Reports for their equipment
When companies get ready early for a CDSCO inspection, they can avoid getting held up (which is one of the biggest reasons companies will be delayed in getting their approvals).
10. Implement a Structured Post-Submission Monitoring and Response System
After an application is submitted, it is critical to have a centralised method for monitoring the application and to create systems to ensure that the following are met for companies that utilise the SUGAM platform:
Constant efforts to monitor SUGAM.
Acknowledgement of queries from CDSCO.
Responses to queries within 48-72 hours.
Corrections in communication with one designated point of contact for each.
When fast, comprehensive, and scientifically justified responses are provided, review periods are significantly shorter.
Conclusion
The CDSCO will provide faster approvals for manufacturers in 2025 as a result of strategic planning, scientific integrity, and strict adherence to standard operating procedures (SOP) rather than through the use of 'shortcut' methods. The following strategies will ensure that a manufacturer is successful in the approval process and, ultimately, will receive their product(s) quickly through the aforementioned items:
The Correct Pathway to Securing Regulatory Approval
Proactive Interaction with Regulatory Authorities
High-Quality Dossiers Submitted
Transparent Communication with Regulatory Authorities
Show Strong Pharmacovigilance and Manufacturing Systems
Through the use of the above strategies, manufacturers can expect to have their regulatory submissions processed more smoothly and also receive quicker regulatory approvals.
Regulatory Approvals will be done via Evidence-Based Approaches and through the Effective Use of All Resources Available to Gain Regulatory Approval for Drug Products in India!
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