Hydroxychloroquine, one of the oldest and best-known anti-malarial drugs, it is very similar to chloroquine and has lesser side-effects. It can be bought over the counter and is cheap. It is an anti-malarial drug, promoted as a game-changer in the fight for coronavirus. Chloroquine and hydroxychloroquine are efficient on SARS-CoV-2 and reported to be efficient in Chinese COV-19 patients. Every month, India can produce 40 tonnes of hydroxychloroquine (HCQ), implying 20 crore tablets of 200 mg each.
The manufacturers have good production capacities that can also be ramped up since the drug is also used to auto-immune diseases like rheumatoid arthritis and lupus. India supplied 47% of US drugs last year, Actavis; a subsidiary of Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA) is one of the very few of suppliers in the top 10 which is non-Indian and even then, it is likely that some of their production facilities are nevertheless located in India. They are the biggest maker of generic drugs in the world. The supply of most of the hydroxychloroquine to the USA comes from makers in India, which has now been stanched after the Asian nation banned exports of all forms of the malaria drug termed as a game-changer by President Trump for treating the coronavirus.
Why did India ban the export of pharmaceutical drugs?
The largest producer of HCQ, India, wanted to ensure adequate domestic supplies so it had initially banned exports of the drug on March 25. The exports of HCQ and formulations made from special economic zones (SEZs) and export-oriented units (EOUs) were barred on April 4th, the bans do not usually apply to SEZs and EOUs, which are meant to promote exports.
The US president said that he would retaliate if the ban is not removed, hence on April 7, India’s Ministry of External Affairs said it has temporarily licensed paracetamol and HCQ export to some countries which have been particularly badly affected by the coronavirus pandemic. Restrictions on 12 products and its formulations have been withdrawn by the government after assessing that it will be able to meet both the domestic demand and export obligation for Paracetamol and hydroxychloroquine. Sri Lanka and Nepal, India’s immediate neighbors have also requested HCQ supplies. India is to export the anti-malarial drug hydroxychloroquine (HCQ) to some countries, after US President’s retaliation; since the drug is not manufactured in developed nations such as the US because of the non-existence of malaria. Seventy percent of all the active pharmaceutical ingredients (APIs) needed by India to manufacture drugs come from China.
Is HCQ Drug effective?
It is not officially approved for such use, there is a suggestion that HCQ is effective in the treatment of some symptoms of COVID-19. The short-term use of the drug can cause cardiac arrhythmias, seizures, dermatological reactions, and hypoglycemia, hence it is not without risks. Anurag Srivastava, Ministry of External Affairs spokesperson said that India has always maintained that the international community must display strong solidarity and cooperation. On the humanitarian aspect of the pandemic, India would license paracetamol and HCQ in appropriate quantities to all dependent neighboring countries. The drug availability for all possible domestic contingencies had been confirmed and then the restrictions were lifted. The major API makers for the drug in the country are Zydus, Ipca and Mangalam Drugs. Ipca, Zydus, Wallace Pharmaceuticals, and Cipla are the major formulation makers of hydroxychloroquine.
The test conducted to test the effectiveness of HCQ
In a single-arm protocol COVID-19 patients were included from March to March 16th, the French had confirmed, to receive 600mg of hydroxychloroquine every day. In a hospital setting their viral load in nasopharyngeal swabs was tested. During the clinical presentation, Azithromycin was included in the treatment, untreated patients from another center and cases refusing the protocol were included as negative controls. The endpoint was considered by the presence and absence of a virus on Day6. The results were concluded: Asymptomatic patients- 6, patients with upper respiratory tract infection symptoms-22 and patients with lower respiratory tract infection symptoms-8.
Twenty cases were treated in this study and showed a significant reduction of the viral carriage at D6-post inclusion compared to controls, and much lower average carrying duration than reported of untreated patients in the literature. Azithromycin added to hydroxychloroquine was significantly more efficient for virus elimination. The conclusion is that hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin, the test was effective even though it was conducted in a very small sample size.
Orders placed with Ipca and Zydus Cadila
HCQ is considered as a preventive medication for Covid-19 high-risk groups by the Indian Council of Medical Research (ICMR), 100 million tablets order has been placed by the Indian government with local drug makers Ipca Laboratories and Zydus Cadila, these two companies have been bagged as the top Indian HCQ producers from the Ministry of Health and Family Welfare. NPPA states that just three firms in India can easily produce 40 metric tonnes of HCQ every month, the production can be jacked up accordingly. The Chairman of the National Pharmaceutical Pricing Authority (NPPA), said that the domestic drug makers have sound production capacities at their disposal and the drug is also used for rheumatoid arthritis
How HCQ Drug will be used for Covid-19 treatment
Hydroxychloroquine API had been exported by India in April-January 2019-20 period worth USD 1.22 billion and the exports of formulations made from hydroxychloroquine were at USD 5.50 billion. The people involved in the care of suspected or confirmed cases of the coronavirus and asymptomatic household contacts of laboratory-confirmed patients, apart from healthcare workers who are there in the treatment of COVID-19 have been recommended for the use of the drug. A 14-tablet course is needed by each COVID-19 patient.
How will India produce more drug?
India will divert the production lines of other drugs and temporarily ramp up the output of key medicines to fight the novel coronavirus. Ivermectin, is a promising drug for Covid-19 treatment, prescribed to treat roundworms and scabies. The Indian pharmaceutical industry has the largest number of US Food and Drug Administration (USFDA) approved manufacturing facilities outside the US. It also has the World Health Organisation (WHO) compliant 1,300 manufacturing plants. The drug producers like Indian Drugs and Pharmaceuticals Ltd (IDPL) and Hindustan Antibiotics Ltd (HAL) can be revived by India to increase the production, including active pharmaceutical ingredients (APIs) and key starting materials (KSMs). Diversified suppliers of these are needed by the world.
India needs to lower its dependence on API requirements
Around 60% of the overall requirements of APIs of Indian drug producers come from abroad; for certain specific APIs it is even as high as 80-90. It needs to be changed, a revamped policy for pharmaceuticals is needed so that the domestic manufacturing capacity can be restored and revived in APIs and KSMs that is globally competitive and price-efficient.