EMERGENCY USE Approval to Foreign Vaccines; Of the Needy Options

EMERGENCY USE Approval to Foreign Vaccines; Of the Needy Options
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The sudden outbreak of Covid- 19 has devasted almost every corner of the globe posing an arduous challenge against human civilization. Continuous-wave battle one after another claiming lives of millions strong, fragile, women, children, etc. It rose indomitable, proving all human efforts to subdue it futile leaving vaccines as the most critical of the tools to fight the battle.

Our human advanced scientific research’s assistance took almost a year to develop a vaccine to combat this COVID-19 with UK’s approval nod to the world’s first vaccine Pfizer & BioNTech. It was after a long wait India approved Covishield, a brand of the Oxford- AstraZeneca vaccine manufactured by SII and Covaxin developed by Bharat BioTech for emergency use on  January,3 2021. These were a relieving development to entire humankind for a short while that was followed by the hope of getting an early jab. Having come far with a preferential inoculation strategy, Hon’ble PM on a fortunate evening of April 19 announced that all above 18+ will be eligible to get the vaccine from May 1. 

Unfortunately, a couple of days before the scheduled vaccination, states are made to announce that no vaccination for 18+ could take place on the scheduled May 1st day due to lack of stock with the states as no required doses were allocated and supplied by the Central Government to respective states. And only after more than two weeks from the scheduled day, vaccination drive for 18+ beneficiaries started. And it precisely started from May 16, 2021, in our state Sikkim. Till yet, the inoculation program for 18+ and below 45 is not implemented in full-fledged in Indian states including Sikkim save the East District where also only 5 centres are administering vaccine currently due to an adequate supply of doses by the Union Govt.

In phase-III of the National Vaccine Strategy, India announced the implementation of liberalized Pricing and Accelerated National Covid-19 Vaccination Strategy (LPANCVS) policy in India since 1st May 2021. Point 7 of the LPANCVS clearly states that the implementation of the policy aims to liberalize vaccine pricing and scale-up of vaccine coverage. This would, on one hand, incentivize vaccine manufacturers to rapidly scale up their production and on other hand, it would also attract new vaccine manufacturers. It would make pricing, procurement and administration of vaccines more flexible and ensure augmented vaccine production as well as wider availability of vaccines in the country.

With the implementation of the Liberalized Pricing and Accelerated National Covid-19 Vaccination Strategy (LPANCVS)policy in India since  May 1 2021, vaccine manufacturers will supply 50% of their monthly Central Drugs Laboratory (CDL) released doses to Govt. of India and only the remaining 50% doses would be available to the private sector, State Govts., UTs & in other than Govt. of India channel for direct procurement. The Central Government procured 50% doses are allocated free of cost to the States/UTs based on the criteria of performance (speed of administration, average consumption), the extent of infections (number of active Covid cases).

However, even with the implementation of the liberalized policy, the Central government is able to gain its control substantively to the extent of procurement by State governments by determining the state’s requirement on a pro-rata calculation of the population basis. With central government retaining substantive control over the vaccine procurement, state governments are left with near to least at hand for procurement from Indian approved manufacturers as against their need.

Following the implementation of the policy in May 1, 2021, many states floated a global tender for the supply of the Covid vaccine. Andhra Pradesh became first amongst Indian states along with the Bombay Municipal Corporation being the first municipal corporation in the world to float global tenders for Covid-19 vaccines on 13th May. Likewise, the states of Odisha Telangana, Tamil Nadu, Karnataka, Delhi Govt., Punjab, etc. floated a global tender for the supply of the vaccine doses at different dates according to their requirements as the central govt. allocated doses are inadequate.

However, despite the state’s proactive step for procuring vaccines by floating global tenders in meeting the vaccination need of the state, the WHO, US FDA, UK MHRA, EMA, PMDA Japan approved vaccines such as Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, Sinopharm COVID-19, ComirnatyCOVID-19 Vaccine, Vaxzevria (previously COVID-19 Vaccine AstraZeneca) are yet not qualified bidders as far as its usage in India is concerned due to lack of regulatory approval except only the Russia’s Sputnik vaccine through Dr. Reddy’s labs. It is only after the regulatory approval is obtained from the Drugs Controller General of India, these WHO, US FDA, UK MHRA, EMA, PMDA Japan approved vaccines becomes eligible to be administered in India thereby making them eligible to take part in the global tender.

The approved vaccines have to undergo the rigour regulatory approval from the DCGI in the following nature:

  1. An applicant can submit an application for approval of Covid- 19 Vaccines for restricted use in an emergency situation in India through the SAUGAM online portal along with requisite fees and requisite documents in Common Technical Documents format in Guidance for Industry along with requisites as sought in the NOTICE of the Director-General of Health Services Central Drugs Standard Control Organization (Public Relation Office) as “Guidance for Approval Covid- 19 Vaccines in India for restricted use in an emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which listed in WHO Emergency Use Listing (EUL)” dated 15th April 2021.
  2. Application submitted by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian Subsidiary) via SAUGAM online portal shall be as per the New Drugs and Clinical Trials Rules, 2019 (Rule 21) under Drugs and Cosmetics Act, 1940.

The relevant Rule reads as under:

“Rule 21. Application for permission to conduct a clinical trial of a new drug or investigational new drug. ― (1) Any person or institution or organization which intends to conduct a clinical trial of a new drug or an investigational new drug shall make an application to the Central Licensing Authority duly filled in Form CT-04.

(2) The application made under sub-rule (1) shall be accompanied with the information and documents as specified in the Second Schedule(REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT OR MANUFACTURE OF NEW DRUG FOR SALE OR TO UNDERTAKE CLINICAL TRIAL) and fee as specified in the Sixth Schedule:

Provided that no fee shall be payable for the conduct of a clinical trial by a person of an institution or organization funded or owned, wholly or partially by the Central Government or by a State Government.”

Application for permission to import or manufacture the new drug for sale or to undertake clinical trials under these Rules shall be made to the Central Licensing Authority accompanied with the following data in accordance with Table 1 or Table 2 or Table 3 or Table 4 of this Schedule.

  1. An application for Restricted Use in Emergency Situation is processed by the Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, GoI as per New Drugs & Clinical Trial Rule, 2019.
  2. As per the notice of the Director-General of Health Services Central, Drugs Standard Control Organization dated 15th April 2021, the foreign manufacturer/s along with the application for Use in Emergency Situation are also required to apply for Registration Certificate and Import License and the Drugs Controller of India will process the application so received.
  3. After approval of the Restricted Use in Emergency Situation by the Drugs Controller General of India, and only after obtaining Registration Certificate and Import License as per the protocol of CDSCO, the applicant is required to have every batch of the vaccine tested by the Central Drugs Laboratory (CDL) before it can be used as per the National Vaccination Program.
  4. Again, the CDI released vaccine is to be administered amongst 100 beneficiaries at first of which 100 beneficiary’s safety data should be submitted to the CDSCO. And only after a satisfactory review of safety data submitted by the Expert Panel of the CDSCO, that particular vaccine will be allowed to use.
  5. The DCGI will also review the permission of Restricted Use in Emergency Situation after the receipt of the bridging trial results.

 

Having these extensive Drug regulations in India, vaccine manufacturers which already has the approval of Emergency Use from reputed agencies are losing their interest in availing market in India for their vaccines. Also, the state’s proactive steps for procuring vaccines on their own is dependent upon the policy of individual vaccine manufacturers as Punjab’s global tender for procuring vaccines was turned down by one of the approved vaccines Moderna, stating it does not supply directly to the states.

At this time of difficulty, states are left with the least scope to take proactive steps to procure vaccine on their own in order to meet the vaccine demands to inoculate their respective populace. Procurement of vaccine globally is obstructed due to the extensive vaccine regulation in India as a result of which, even the reputed agencies [US FDA, EMA, UK MHRA, PMDA Japan or which listed in WHO Emergency Use Listing (EUL)] approved vaccines are not yet granted Emergency Use in India. Also, the Central Government not acting as a Nodal Agency to float global tender on behalf of states is further posing difficulty as the procurement is dependent on individual manufacturer’s policy as in the case of Moderna.

The vaccine procurement by states from domestic/ Indian approved vaccines are equally inadequate to ease the state’s burden in mass vaccination because of the left 50% (after 50% procurement by Central Government) doses, it is to be equally distributed amongst the private sector including Union Territories and States that is solely to be disbursed on pro-rata calculation of the population basis. Doing away with this pro-rata calculation will not help the way because it is very likely to accrue disparity amongst the most influential and economically sound states.

Indian Government needs to immediately rethink its Drug Regulations and ease the same in granting Emergency Use approval to all the approved vaccines in India taking into account the least essential procedures to be meted by the foreign manufacturers. The best of the options left to combat the virus is to inoculate most of the populace and the best of the options available to India at this juncture is to ease approval regulation to foreign manufacturers keeping the least essential procedural requirements.

By Sayshay Hang Limboo. The author can be contacted at sayshayhang97@gmail.com