The government has allowed the private sector to step in and vaccinate staff. Pharma legal expert Shantanu Mukherjee and co-author Sampreetha Kumar explain how to navigate setting up a vaccination facility for your employees
Policy revised
The government revised its vaccination policy again on 8 June. The revised vaccination guidelines now say, among other things, that domestic vaccine manufacturers must supply 75% of their capacity to the union government but can continue to reserve 25% of their production for sale (at prices set by them) to private hospitals. The prices that such hospitals may charge for these vaccines have, however, now been capped: at INR 780 for Covishield, INR 1410 for Covaxin and INR 1145 for Sputnik V. Interestingly, while the revised guidelines say “All citizens are entitled to free vaccination”, it encourages those who have the ability to pay to use vaccination centres at private hospitals. As such, it is likely that corporate vaccination drives will continue to play an important role in vaccinating urban India.
When the government first launched its covid-19 vaccination programme on 16 January 2021, only it could procure and distribute vaccines.
The Ministry of Health and Family Welfare (MOHFW) had already issued its Covid-19 Operational Guidelines, on 28 December 2020, outlining its vaccination plan and related strategies, which contemplated ongoing engagement with the private sector, and vaccinations through private health facilities.
As part of this planned engagement, the ministry then issued a guidance note, dated 6 April 2021 (MOHFW note), called covid-19 Vaccination at Workplaces, outlining the conditions under which private-sector employers could organise vaccination camps at the workplace for their employees (but not their family members).
Such camps were to be organised in collaboration with private healthcare facilities registered as private covid vaccination centres (PCVCs), which could purchase vaccines from the government and “partner with” private sector employers to administer vaccines at employee vaccination camps. Such PCVCs could charge no more than INR250 (USD3.40) per person per dose for such vaccinations.
Matters became rather more complicated with the government’s Liberalised Pricing and Accelerated National Covid-19 Vaccine Strategy, which came into effect on 1 May 2021. Under the new policy:
- The vaccination programme was expanded to cover those aged 18-44, and allowed state governments and private hospitals to buy vaccines approved for use in India directly from domestic vaccine manufacturers, at prices set (and declared in advance) by such manufacturers;
- Private hospitals could no longer buy vaccines from the government. At the same time, the cap on what they could charge for vaccinations was removed;
- The government would continue to vaccinate healthcare workers, frontline workers and citizens aged 45 and over; and
- The state governments could theoretically begin to vaccinate citizens under 45, but, being short on vaccines, were encouraged by the central government to prioritise citizens aged 45 and over.
The new policy essentially created a second, more expensive, “free market” vaccination programme, running parallel to programmes of the central and state governments.
The health ministry then clarified, on 19 May 2021, that workplace vaccination camps could cover all employees aged over 18 years, but not their family members (echoing the position in the MOHFW note).
Meanwhile, the Central Drug Standard Control Organisation (CDSCO) issued a public notice on 4 May 2021 (titled “Guidance for import of vaccine by private sector or any person”), which appeared to allow imports of vaccines by the private sector, prompting corporates to wonder whether they could directly import vaccines into India and, if so, which ones.
The authors will attempt, via questions and answers, to make sense of the regulatory landscape that applies to private sector employers who organise vaccination camps for the benefit of their employees.
Q. Which vaccines are authorised for use in India?
There are three – Covishield, Covaxin and Sputnik V.
On 3 January 2021, the CDSCO approved two vaccines for restricted emergency use:
- Covishield, developed by Oxford-AstraZeneca and manufactured in India under licence by the Pune-based Serum Institute of India; and
- Covaxin, developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.
Then, on 12 April 2021, the CDSCO approved Sputnik V, developed by Moscow’s Gamaleya Institute, which is being imported into India by Dr Reddy’s Laboratories, and being contract manufactured under licence by Panacea Biotec.
No other vaccines have been approved yet, although Zydus-Cadila will likely seek emergency-use approval for its three-dose vaccine, currently in phase III trials, in June 2021. Hyderabad-based Biological E has received approval to begin phase III trials of its own two-dose vaccine, and expects to produce 75-80 million doses a month from August 2021, subject to approval. It also has a licence to contract manufacture 600 million doses of Johnson & Johnson’s single-dose vaccine, which has not yet been approved for use in India.
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Shantanu Mukherjee is the founder of healthcare boutique firm Ronin Legal and Sampreetha Kumar is an intern there. Mukherjee was the former legal head – APAC and Japan of pharma company Lupin and the former global legal head, M&A at Cipla. He can be reached at shantanu@roninlegal.in
