An ampoule of remdesivir is pictured during a news conference at the University Hospital Eppendorf in Hamburg, April 2020. Photo: Ulrich Perrey/Pool via Reuters
- The Parliamentary standing committee on chemicals and fertilisers has produced a report highlighting gaps in the availability of COVID-19 drugs and devices during the pandemic.
- The committee has asked the national government why PSUs didn’t receive licenses to make COVID drugs when private manufacturers did.
- The MPs on the committee also spotlighted widespread irrational drug use in COVID-19 management, despite the existence of a standard treatment protocol.
New Delhi: The Parliamentary standing committee on chemicals and fertilisers has said it is surprised that the Union government didn’t use public sector facilities in the country to ramp up production of COVID-19 drugs.
The committee said the Union government had expeditiously approved the production of remdesivir at 40 new manufacturing sites, after the ferocity of the country’s second COVID-19 outbreak precipitated an acute shortage of drugs at pharmacies.
“The Committee fails to understand that none of the Pharma Public Sector Undertakings under the Department of Pharmaceuticals have been granted voluntary licence to manufacture Remdesivir and other COVID essential drugs for public health supply,” the committee’s report read.
“Equal opportunity should also be extended to these Pharma PSUs who have developed trust, quality and cost effectiveness in their pharma products over a long period of time.”
The committee comprises 30 members of the Lok Sabha and the Rajya Sabha, and is chaired by Dravida Munnetra Kazhagam MP K. Kanimozhi. It presented its report earlier this week.
Committee members also said they were uneasy about the widespread irrational use of drugs, in ignorance of the standard treatment protocols. It cited the example of remdesivir again. On June 7, 2021, the government issued a revised treatment protocol for COVID-19, which said remdesivir could only be used with COVID-19 patients who had moderate to severe illness.
“The prescription of Remdesivir was rampant during the second wave of COVID-19 pandemic rather than its prescription only in [a] select subgroup of patients with moderate to severe disease,” the report said.
The committee pinned this on a lack of awareness in the medical fraternity and has advised the Union government to organise “nationwide online training programmes for all registered medical practitioners whether in Government or Private hospitals”.
Incidentally, the Indian government used to organise webinars for doctors; the committee report indicates that they didn’t solve this particular problem.
The committee of MPs also took cognisance of “large-scale black marketing” of COVID-19 drugs and medical devices during the two waves of India’s COVID-19 epidemic. Based on data from state drug licensing authorities, the committee said 317 cases of hoarding or black-marketing/over-pricing have been reported thus far.
Also read: Lack of Definitive COVID-19 Treatment Guidelines Is Leading To Chaotic Medicine
In April 2021, the National Pharmaceutical Pricing Authority (NPPA) set up a control room to record complaints vis-à-vis the availability of medicines. However, the body only received 38 complaints, according to the committee, and which were low compared to the “actual number of such indulgences”.
“This clearly implies that there is very [little] awareness among people about the present complaint/grievance redressal mechanism,” the report concluded, advising the government to step up public awareness of the rational use of COVID-19 drugs. It also recommended “prompt” action against black-marketeers.
The overall report also asked the government to frame a new price control regime for medicines and medical devices specific to COVID-19 management.
Currently, there are two categories of drugs and devices. Some of them come under the NPPA’s purview, and it fixes the ceiling price of these products. They are called ‘scheduled drugs’, as specified in the first schedule of the Drugs (Prices Control) Order 2013.
On the other hand, a manufacturer of a non-scheduled drug can fix the maximum retail price on their own, as long as it has not increased by more than 10% in the previous 12 months.
But according to the committee, all COVID-19 drugs and medical devices should be treated as ‘scheduled’ and have their prices be capped. “The Committee hopes the Department of Pharmaceuticals and NPPA will understand the gravity of the situation and will take immediate necessary action on this recommendation within a stipulated time frame,” it wrote in its report.
The MPs identified two major bottlenecks in ensuring the availability of drugs during India’s two COVID-19 outbreaks.
One was the time lag between manufacturing and actual availability in the market.
The other was the country’s reliance on other countries for active pharmaceutical ingredients and raw materials known as excipients. The group asked the government to take “all necessary measures” on a “war footing” to end this, and also said the external affairs ministry could help Indian manufacturers procure raw materials.
The standing committee’s recommendations are not binding on the national government. However, the committee has expressed hope that the government will act to overcome those shortcomings enumerated in the report, to respond better to future disease outbreaks.