Context: After imposing a blanket ban on the export of anti-malaria drug hydroxychloroquine on April 4, without exemptions on humanitarian or other grounds, India reversed the policy two days later.
Background: The U.S. Food and Drug Administration issued an emergency use authorisation for the drug to treat COVID-19 patients, on April 7,
- Diplomatic fallout: The decision to reverse the ban was made public hours after U.S. President Donald Trump warned of “retaliation” if India withheld supplies of the drug for which orders had already been placed.
- Also, India may have much to gain from the U.S. in the future by this diplomatic act of supplying the drug at a crucial time.
- Countries displaying solidarity : Lauded as the pharmacy of the global south, India’s decision to export the drug on humanitarian grounds to neighbouring countries and others that have been badly hit by the pandemic is welcome.
- India’s current capacity:
- Production capacity is considered sufficient to meet the current demand.India has a production capacity of 200 million hydroxychloroquine tablets of 200 mg strength each month and three well-established pharmaceutical companies make the drug.
- The companies are confident of ramping up production if the need arises.
Regulating the use of hydroxychloroquine
- The Indian Council of Medical Research approved its use as prophylaxis for novel coronavirus by certain categories of people on March 23.
- Later, the drug was placed in the restricted category for export and included in schedule H1 on March 26 to prevent its sale over the counter, thereby preventing self-medication and hoarding.
- This was also to ensure its availability to people with rheumatoid arthritis and other conditions.
Under the Drugs & Cosmetics Rules, drugs specified under Schedule H and Schedule X are required to be sold by retail on the prescription of a Registered Medical Practitioner only.
- The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.
- The drug specified in Schedule H1 shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border.
Utility of HCQ with respect to COVID 19:
- It is being studied as an experimental treatment for coronavirus disease 2019 (COVID-19).
- Hydroxychloroquine is an interferon blocker ,and works by diminishing the immune system’s response against a viral disease.
- A hyperactive response of the immune system is said to be primarily responsible for pneumonia caused by severe COVID-19.
- Interferons:They are a group of signaling proteins made and released by host cells in response to the presence of several viruses.
- The Indian Council of Medical Research (ICMR) recommends the use of hydroxychloroquine as a prophylactic (preventive care) for asymptomatic healthcare workers and contacts of people who have been infected by the virus.
- The ICMR’s decision on wider use of the drug will depend on further research.
- On a global level:
- A study by Chinese researchers, in February, for instance, showed that the drug speeded up the recovery of COVID-19 patients who had suffered pneumonia.
- In International Journal of Antimicrobial Agents (IJAA) few French scientists reported that Azithromycin (an antibiotic) added to hydroxychloroquine was significantly more efficient for virus elimination
- Moreover some of the early naysayers of the drug, including the US Food and Drug Administration, have now come around to recommending its use in emergency situations.
- Unproven drug: However dosages are linked to instances of cardiac arrhythmia and liver damage. Wide usage may actually handicap patients ability to fight the infection.
The Atlanta-based Centers for Disease Control and Prevention revised its position saying there is no drug available to prevent or treat COVID-19. Clearly, more research work is needed to establish the efficacy of the drug.
- It is a medication used to prevent and treat malaria in areas where malaria remains sensitive to chloroquine.
- This medication is also used, usually with other medications, to treat certain auto-immune diseases (lupus, rheumatoid arthritis) when other medications have not worked or cannot be used.
- It is taken via the oral route.
- It is sold under the brand name Plaquenil among others.
- It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system.