Asia-Pacific Roundup: India seeks feedback on creating regulatory framework that supports innovation

India has proposed regulatory reforms intended to encourage R&D and innovation in the pharma and medtech industries. The proposals are part of a broader plan to make India a leader in drug discovery and innovative medical devices by establishing an entrepreneurial environment in the country.
 
In working toward the goal, the Department of Pharmaceuticals (DoP) is proposing to simplify India’s regulatory processes to enable rapid drug discovery and innovation in medical devices. As DoP sees it, the Indian framework needs to expand beyond “the traditional regulatory objectives of safety and quality” by starting to “differentiate in favor of innovation.”
 
DoP has identified barriers to the realization of its objective. First, the department has determined that the presence of “multiple agencies with different mandates and expertise that an Innovator firm has to navigate” means new products and innovations that “fall outside the existing standards” may lack “clear processes.” DoP said India’s modified Clinical Trial Rules and the Medical Device Rules address some, but not all, of the gaps.
 
Second, DoP said the regulatory capacity within the government needs to keep pace with advances in science and technology, thereby enabling authorities to rely less on “ad-hoc external inputs.” The lack of internal expertise in emerging areas “contributes to long timelines for grant of approval to innovative products,” DoP said.
 
Faced with the challenges, DoP is proposing to create a Common Specific Procedure Pathway (CSPP) for each class of product. The pathway would include “checklists, prescribed timelines, parallel processing, joint inspections, automatic/deemed approvals, and sharing of data across regulators.” CSPP forms part of the department’s plans to make regulators work together, reduce overlaps and thereby cut the time taken for approvals of innovative products by at least 50% in the next two years.
 
DoP is also proposing to create a digital portal, hosted by India’s Central Drugs Standard Control Organization (CDSCO), which will serve as a single interface between innovators and all the agencies involved in overseeing the development and approval of their products. The portal will automate the transfer of data between departments and use “artificial intelligence-backed dossier review and deficiency identification ... to enhance efficiency and reduce human interface.” The ultimate goal of the portal is to bring transparency, timeliness and predictability to regulatory processes and outcomes.
 
Other aspects of the proposal cover regulatory capacity and legislation. DoP wants to strengthen CDSCO with “project management roles to provide dedicated support to the industry Innovators.” That side of the strategy includes the addition of expertise in biopharmaceuticals and “high end medical devices.” DoP also wants India’s National Pharmaceutical Pricing Authority to add expertise “in pricing of new innovative products, while pursuing affordability as an overall objective.”
 
Finally, DoP is proposing to review the legislation covering biopharma and medtech R&D. The plan is to remove inconsistencies and redundancies, for example by exempting some products from India’s Biological Diversity Act and by enabling CDSCO and state regulators to conduct joint inspections.
 
The draft is open for comment until 6 November.
 
Draft Policy
 
TGA updates approach to GMP oversight of foreign manufacturers as COVID-19 drags on
 
Australia’s Therapeutic Goods Administration has updated its good manufacturing practice (GMP) approach to overseas manufacturers during the COVID-19 pandemic in light of ongoing limitations on its activity abroad.
 
TGA put remote inspections at the center of its revised approach to GMPs last year. Today, TGA is working through “a large number of Certification applications following the suspension of overseas GMP inspections” and adapting its approach. TGA is no longer contacting sponsors before including them in its remote inspection program because there is no other option for certification applications.
 
The volume of work has led TGA to prioritize remote GMP inspections based on the ability to use the alternative GMP Clearance processes, current compliance information and applications for marketing authorization.
 
Regarding alternative processes, TGA is still allowing manufacturers that had an on-site inspection in 2018/2019 to complete a GMP Clearance questionnaire to verify their compliance. TGA has revised the policy in light of the lack of in-person inspections by its regulatory peers, allowing companies to file remote inspections reports to support or, in some cases, replace the GMP Clearance questionnaire. Remote inspection reports cannot be used as the primary evidence of GMP Clearance, though.
 
The guidance also addresses the “large number of GMP Clearances” that are set to expire at the end of the year for reasons related to TGA’s mutual recognition agreement partners, including European pandemic guidance. TGA will extend the validity of GMP Clearances beyond the recommendations of its partners where possible, factoring in elements such as the type of manufacturing steps performed at the facility and the length of time since the last physical inspection into its decision.
 
TGA Guidance
 
Pakistan releases draft guidelines on imports and exports of therapeutic goods
 
The Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines that describe the requirements for commercial imports and exports of therapeutic goods including finished products and active ingredients.
 
DRAP’s draft covers the documentation needed to move therapeutic goods in and out of Pakistan, details of how to determine eligibility to import and export products, and an overview of verification and port clearance procedures. Another section of the text describes the responsibilities of entities involved in import and export.
 
Different sections of the draft address the rules on pharmaceuticals and biologics and, more briefly, medical devices and alternative medicines. DRAP is yet to publish a timeline for finalizing the draft and bringing the guideline into effect.
 
DRAP Notice
 
TGA adds Bharat and Sinopharm COVID-19 vaccines to list of jabs recognized in Australia
 
TGA has added Bharat Biotech’s Covaxin and Sinopharm’s BBIBP-CorV to the list of COVID-19 vaccines that are recognized in Australia for the purpose of determining if a traveler is vaccinated.
 
Neither vaccine is registered for use in Australia. However, as the country opens up to international travel, it will allow visitors from overseas who have received Covaxin or BBIBP-CorV to benefit from the more relaxed requirements imposed on people who have been vaccinated against COVID-19.
 
The vaccines were absent from the list of products originally recognized by TGA. The agency changed its position after receiving “additional information demonstrating these vaccines provide protection and potentially reduce the likelihood that an incoming traveller would transmit COVID-19 infection to others while in Australia or become acutely unwell due to COVID-19.”
 
TGA’s revised policy will particularly affect people in China and India, where the two vaccines have been widely used, and therefore “have significant impacts for the return of international students, and travel of skilled and unskilled workers to Australia.”
 
TGA Notice
 
Indonesia becomes the first country to authorize Novavax’s COVID-19 vaccine
 
Novavax has finally received authorization for its COVID-19 vaccine. Indonesia became the first country to grant emergency use authorization (EUA) to the recombinant nanoparticle protein-based COVID-19 vaccine.
 
The EUA comes 10 months after Novavax reported top-line data from a 15,000-subject UK Phase 3 clinical trial and more than four months after the company delivered results from a larger US study. Both trials found the vaccine was around 90% efficacious, albeit against different variants than those circulating today, but manufacturing issues held up filings.
 
Novavax expects the EUA in Indonesia, where Serum Institute of India will sell the vaccine, to be the first of many authorizations in the coming weeks. While many countries have already vaccinated their populations, the storage requirements of Novavax’s vaccine mean it may have a role in parts of the world lacking deep-freeze cold chain capabilities.
 
Press Release