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.

Q. Can private-sector employers directly purchase covid-19 vaccines manufactured in India?

No. Under the new policy, apart from central and state governments, only hospitals and “industrial establishments through their hospitals” are eligible to procure vaccines via the private channel. Therefore, corporates generally procure vaccines from, and conduct vaccination camps through, a PCVC. A list of registered PCVCs is available on the CoWin app.

Q. Can private-sector employers procure vaccines from the government?

No. Before the new policy, a company could also purchase vaccines and vaccinate employees in partnership with a government healthcare facility, but now it can only buy vaccines via the private channel.

Q. Are vaccine prices capped?

No, not for private-sector employers. The Serum Institute of India and Bharat Biotech have said they would charge private hospitals INR600 per shot for Covishield, and INR1,200 per shot for Covaxin, respectively, but there is no cap on the prices at which these hospitals may resell. The new policy only says that, “the price charged for vaccination by private hospitals would be monitored”.

In practice, employers will likely find that only a handful of hospital chains have vaccine stocks and are willing to conduct corporate vaccination camps. Further, the prices charged by these hospitals vary significantly around the country, and an employer may have to pay up to double the rates set by the manufacturers.

Q. Can employers import covid-19 vaccines?

No. While the CDSCO guidance of 4 May 2021 may suggest as much, the process laid down by the CDSCO itself for import of vaccines (see CDSCO public notice on Guidance for approval of covid-19 vaccines, dated 15 April 2021) requires that one first procure an import licence and registration from the CDSCO. An application for such a licence may only be made by the foreign vaccine manufacturer’s Indian subsidiary or authorised agent.

To import a vaccine already approved in India, such as Sputnik V, an import licence is sufficient. To import a vaccine not yet approved in India (e.g., the Pfizer or Moderna vaccines), the applicant must also secure a new drug permission by the CDSCO. The organisation has stated that it will “fast track” (make a decision within three days) applications for approval of vaccines that have already received emergency approval for restricted use by the relevant drug regulatory authorities of the US, EU, UK or Japan, or listed for emergency use by the World Health Organisation.

Once a “foreign produced” vaccine has been approved for restricted emergency use in India, as above, an importer or authorised agent with the necessary import licence can import the vaccine, but must:

(1) conduct a “post-approval parallel bridging clinical trial”; and

(2) administer the imported vaccine to 100 recipients, monitor them for seven days for safety outcomes, and then submit the safety data to the CDSCO for approval to sell the vaccine more widely.

Since the new policy requires that corporates buy vaccines through hospitals, this in effect means only private hospitals may procure vaccines from such an importer. The new policy also says that imported vaccines may be “utilised entirely” by state governments and the private sector, the implication being that there is no requirement to reserve half the capacity for the government, as with domestically manufactured vaccines.

Q. What rules and regulations apply to employers that wish to organise vaccination camps?

Under the MOHFW note, any corporate looking to implement a vaccination drive must comply with specific guidelines, including the following:

  • Employers must approach the district task force, chaired by a district magistrate, or urban task force, chaired by a municipal commissioner, to be identified as an eligible workplace;
  • An eligible workplace is one that employs more than 100 people and has three separate rooms for waiting, vaccinating and observation. These three rooms should be stable structures, ideally part of the permanent structure of the workplace. Temporary tent-like structures may not be used;
  • Once identified, the relevant office or workplace is registered as a workplace covid vaccination centre (WCVC) on the CoWin portal; and
  • A WCVC must be tagged to the nearest private health facility registered as a PCVC.

Q. How can I partner with a private covid vaccination centre?

As proper administration of covid-19 vaccines requires trained personnel – and also because only hospitals (apart from the central and state governments) are currently able to procure vaccines – the employer must partner with the nearest PCVC, in practice, probably the hospital through which they procured the vaccines. The tagged PCVC will provide the vaccine and deploy a trained vaccination team to the WCVC.

Additionally, a nodal officer must be identified and designated by the employer, who must oversee and facilitate the vaccination process including:

  • Identify all beneficiaries and ensure their registration on the CoWin portal;
  • Co-ordinate with the tagged PCVC to arrange space and infrastructure; and
  • Ensure that a printed copy of the vaccination certificate is provided to the beneficiaries on-site.

If the employer has captive health infrastructure e.g., health clinics or nursing centres, it may set up a vaccination site – provided there is sufficient space for waiting, and vaccination and observation rooms are available – and use its healthcare workers for the vaccination drive, as vaccination team members. These healthcare workers must be trained by the PCVC tagged to it before deployment.

For every 100 recipients of the vaccine, there must be a fully trained vaccination team consisting of:

  • A team leader, who must be a doctor;
  • Vaccinator authorised to administer injections;
  • One vaccination officer to verify CoWin entries; and
  • Two more vaccination officers for crowd control, and to track adverse events following immunisation (AEFI).

To appropriately tackle adverse events, all workplace covid vaccination centres must:

  • Have a medical officer as a team leader;
  • Have an anaphylaxis kit for management of any adverse event;
  • Be linked to the nearest (no more than an hour away) health facility (AEFI management centre), in case medical management is needed after vaccination; and
  • Have a basic life support ambulance on standby to transport vaccine recipients to the linked AEFI management centre if needed.

Q. Are employers that are based in Mumbai governed by different regulations?

The Mumbai municipal commissioner has separately framed and issued, on 7 May 2021, its Guidelines on covid-19 Vaccination at Workplaces/Housing Societies. These guidelines also cover vaccinations in housing societies, but are generally very similar to the MOHFW note.

Q. Can employers also vaccinate employees’ family members?

Neither the MOHFW note nor the MOHFW letter dated 19 May 2021 allowed employees’ families to be vaccinated at workplace vaccination camps, while the Mumbai guidelines did.

The health ministry received several requests, including from the National Association of Software and Service Companies, to reconsider its position. On 21 May 2021, two days after earlier stating that private employers could not vaccinate their employees’ families, the health ministry then clarified that an employee’s family members and dependents (as identified by the employer) could be vaccinated at a workplace covid vaccination centre, provided the employer procured the vaccines.

Conclusion

At a time of widespread vaccine shortages – where state governments reportedly cannot procure vaccines from domestic manufacturers, but private hospitals can – those fortunate enough to be employed in organisations that can hold vaccination camps realise that such camps represent the only source of access to vaccines, for themselves and their families.

Likewise, employers realise, even if the government initially did not, that employees are not free to return to, or focus on, work while family members remain affected by or vulnerable to covid-19. None of us are safe until all of us are. Corporate vaccination camps alone cannot solve this problem, but they are doing their bit for urban India.


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