Govt moves to check over-the-counter selling of coronavirus drugs

After the two so-called ‘wonder drugs’ surfaced a few days back, which may have a potential to treat coronavirus (COVID-19), people in the country have been trying to procure them over the counter at chemist shops. 
 

Sensing serious health risks, the government has swung into action. Dispensing of these medicines would get stricter and states have started collecting information on available stock in the market. 
 

In order to ensure that sufficient quantities of these drugs are available in the country, the government on Wednesday prohibited export of hydroxychloroquine. This move hit the stock of the largest manufacturer, Ipca Laboratories, which was down almost 3.5 per cent on Wednesday. 

The Indian Council of Medical Research (ICMR) on Monday had recommended the use of hydroxychloroquine for treating health care workers who are handling confirmed or suspected cases of COVID-19. 
 

Any caretaker of a patient can take these drugs according to the doctors. 
 

The possible preventive qualities of the drug combination – hydroxychloroquine and azithromycin – have led to several citizens trying to procure these drugs over the counter at chemist shops. 
 

There can be serious health risks as a result. Hydroxychloroquine is used for patients with rheumatoid arthritis (an auto-immune disorder) and also as a third line therapy in diabetes.  

Sunil Raina, head of the department of community medicine at RP Government College (Himachal Pradesh), said while the drug is being tested in patients with COVID-19, it should not be used by the public as over-the-counter medicine. “There can be contra-indications in certain health conditions, despite the drug being relatively safe. Data on its effectiveness as a treatment is still limited. It is therefore important that we discourage its use as much as we can at this point in time,” he said. 
 

Meanwhile, the Centre has reached out to chemists. “We have made it amply clear to the chemists association that no slack would be tolerated in dispensing of these medicines over the counter. There could be serious health risks if these are used randomly, besides creating an artificial scarcity situation,” said a senior government official. 
 

The All India Organisation of Chemists and Druggists (AIOCD) has directed all the 850,000 chemists affiliated to the body to not dispense hydroxychloroquine, chloroquine, or anti-HIV drugs like lopinavir and ritonavir, along with common antibiotic azithromycin, without a valid prescription. 
 

Rajiv Singhal, general secretary of AIOCD, said all chemists have been strictly directed to not give these drugs on demand to patients unless it is prescribed by a registered medical practitioner having an MD (masters) degree or a pulmonologist. 

Any deviation may be viewed seriously by the department of pharmaceuticals. 
 

“The prescription a patient carries to procure these drugs from a shop would need a hospital stamp on it to avoid any misuse,” said the government official. 
 

Tamil Nadu health secretary Beela Rajesh confirmed that such an issue has come to the government’s notice and the Drug Control Office in the state is taking the stock details from manufacturers for these drugs. 
 

Rajasthan’s health department, too, has written to manufacturers to submit information on manufacturing capacity, dosage forms, current stock and brand names, among others. 
 

A senior government official in Delhi said this exercise is being undertaken pan-Indian to assess the stock situation in the country for such key drugs. 
 

In order to ensure sufficient stock in the domestic market, the government on Wednesday also prohibited export of hydroxychloroquine. 
 

In a notification, the directorate general of foreign trade said while exports of hydroxychloroquine and its formulations are prohibited, special economic zones and export-oriented units would be allowed to do so if they have any export obligation. The government may also allow exports to countries on humanitarian grounds. 
 

This ban, however, is a blow to major manufacturers like Ipca. Recently, the US drug regulator lifted the import alert on Ipca’s plants for hydroxychloroquine and chloroquine. Ipca was not exporting to the US (due to the import alert), but was doing so to other countries. Cadila Healthcare, too, was exporting to the US. 
 

“We have enough production capacity for the drugs here, and that can be easily ramped up. However, the government has now prohibited exports. This was not necessary to ensure sufficient supplies in the domestic market,” said a senior executive of a company that makes the drugs.