NEW DELHI, Jan 5: Molnupiravir, the first covid-specific oral drug to treat
the viral infection that will hit the Indian market next week, has safety concerns.
The drug, priced at Rs 35 a capsule, is manufactured in India by Dr Reddy's
and a few other companies with licence from American pharma giant Merck.
The drug disables coronavirus from replicating by disrupting its genetic code.
Dr Balram Bhargava, Director-General of the ICMR, told a media briefing on
Wednesday that the oral anti-viral pill for covid, therefore, has not been included
in the treatment protocol of the national task force. The drug has safety concerns
like teratogenicity (harmful for foetus when administered during pregnancy)
and mutagenicity (Mutagenicity refers to genetic changes. These are transmissible.
Certain mutagens are also carcinogens). It can also cause damage to muscles
and cartilages.
The ICMR chief said the US has approved the drug only on the basis of data
of 1,433 patients showing 3% decrease in mild to moderate disease. Bhargava
said that the World Health Organization (WHO) and the UK have also not included
it in the national treatment guidelines.
The Drug Controller General of India (DCGI) had last week given emergency authorisation
for use of Molnupiravir as there has been a surge in covid cases in the country,
especially of the highly contagious Omicron variant.
Merck has an agreement with Dr Reddy's and some other companies to manufacture
and supply the drug in India. Dr Reddy's will also export the drug to other
countries. In India, it has been priced at Rs 35 per capsule, a five-day course
needing 40 capsules. It will be available in the pharmacies across India next
week.
Meanwhile, Union Health Minister Mansukh Mandaviya had said that 13 companies
were allowed to make the anti-viral drug in India.
India had 58,097 new covid cases on Tuesday, the total so far going up to 3,50,18,358.
The cases rose steeply from Monday's 37,379.
