Although a plethora of drugs and vaccines were used to manage Covid-19 during the last two years of pandemic, only five medicines, including Paracetamol and Methylprednisolone, have been included in the recently released National List of Essential Medicine (NLEM) 2022 as effective to check the virus spread. All these drugs are also listed in ‘other indications’. Those also included in the Covid management list are Dexamethasone, Enoxaparin and Oxygen.

However, many others which were much sought after during the Covid crisis and were available in the black market could not find a place in the list. The members of the Standing National Committee on Medicines (SNCM) for revision of NLEM 2022 said the non-inclusion was due to results of some drugs being ‘inconclusive’ and some others still being investigated.

Regarding the Covid-19 vaccine such as (COVAXIN, Covishield, Sputnik V, MODERNA and Johnson & Johnson), which were approved in India for restricted use under emergency situation, the SNCM panel found to have established their protective effect and also, their favourable risk-benefit ratio. “However, factors such as duration of protection, protection against various mutants, requirement of boosters, use in special populations and long-term sequelae of vaccination are yet to be established with these vaccines. “Considering these aspects, the committee was of the opinion that with availability of further long-term efficacy and safety data, these vaccines may be considered for inclusion in future,” it stated.

The members of the SNCM deliberated on essentiality of medicines for Covid-19 and opined that “the data of new medications are still not conclusive and complete in regulatory perspective. Therefore, in absence of unequivocal evidence of efficacy and safety, the new Covid-19 medicines have not been included as of now. However, the supportive management has been added in a separate section.” It was noted that the conditional approval/ emergency use approval was granted to some new medicines for Covid-19, keeping in mind the risk of growing pandemic vs the potential benefit (risk-benefit ratio) on the basis of the available in vitro, non-clinical and clinical trial data. However, the panel categorically said, “The data of such medicines is still not conclusive and complete from the regulatory perspective.”

Therefore, in absence of unequivocal evidence of efficacy and safety, these Covid-19 drugs do not qualify all criteria of ‘essentiality’. Hence, the committee did not recommend inclusion of such new medicines for Covid-19 in the list.

The report categorized research for developing drugs for combating the Covid-19 pandemic into three broad areas including repurposing of drug, development of Covid-19 vaccine and Development of new chemical entity (NCE) for the virus treatment based on the etiopathology.

Drugs like hydroxychloroquine (HCQS), ivermectin, azithromycin and  doxycycline  were tried both for prevention as well as for treatment of Covid-19. Some other drugs approved for other indications (such as baricitinib) were also tried by doctors.

Extensive multicentric clinical trials (such as SOLIDARITY –(remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon) were undertaken. Some trials are still continuing, and data continues to emerge, the panel noted, citing reasons for not including them under the NLEM-22.