Drugmaler Hetero is first generic to get WHO pre-qualification approval

Subject :Science and Technology

Context:

Drugmaker Hetero said it has received World Health Organization (WHO) prequalification approval for its generic version of Pfizer’s Covid-19 oral antiviral treatment candidate nirmatrelvir.
Hetero’s combi-pack Nirmacom will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet).
WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate Covid-19 patients at the highest risk of hospital admission, such as unvaccinated, aged or immunosuppressed patients.
Hetero has already received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market Nirmacom. (eom).

WHO Pre-qualification approval

A WHO pre-qualification, or Emergency Use Listing (EUL), is necessary for a vaccine company to supply vaccines to global facilities such as COVAX or international procurement.
The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

To be eligible, the following criteria must be met:

The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children).
Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines).
The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs.
The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.

Emergency Use Authorisation (EUA) in India

Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered.
In India, the regulatory authority is the Central Drugs Standard Control Organisation(CDSCO).
The approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials.
This is a long process, designed to ensure that medicine or vaccine is absolutely safe and effective.
The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed.

Accelerated Approval Process in India

Under this process, a new drug is approved based on data generated in clinical trials. The Rules provide a relaxation for skipping Phase III clinical trials, which crucially test for a vaccine or drug’s efficacy in preventing disease in the local population.
Phase III trial is allowed to be skipped if ‘remarkable efficacy’ is observed with a defined dose in the Phase II clinical trial of the new drug.
The regulator can then also grant market approval for the new drug or vaccine based on Phase II data to meet what the Rules call ‘unmet medical needs of serious and life threatening diseases in the country’.
The Rules also state that in such cases, additional studies ‘may’ be required after approval to generate data on a larger population to verify its benefits.
Unmet medical needs essentially means a situation where treatment or diagnosis of disease is not addressed adequately with the available therapy.
Further, the Rules provide for relaxations for unapproved or imported drugs or vaccines. The regulator relies on clinical trial data generated abroad to approve the vaccines in such scenarios and additional non-clinical or clinical data may be required to back the claims.

Exceptions for emergency

In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals.
However, there should sufficient evidence to suggest a medical product is safe and effective.
Final approval is granted only after completion of the trials and analysis of full data; until then, EUA allows the medicine or the vaccine to be used on the public.
India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.