Based on the Drugs Technical Advisory Board (DTAB) meet recently, government is mulling over the proposal to include oseltamivir phosphate and zanamivir formulations, antiviral drug used to treat swine flu under the Schedule H1 of the Drugs and Cosmetics Rules. Pharma companies has also proposed to the government to rescind the notification dated September 15, 2009 restricting the sale of these drugs as specified under Schedule X to overcome its restrictive sale.

Gazette notification issued on September 15, 2009 under the Drugs and Cosmetics Act had imposed restriction for stock and sale of oseltamivir phosphate and zanamivir formulations as a Schedule X Drug. According to pharma companies, this has impacted the sale and distribution of drug.

According to chemists, lifting restriction will allow over 4 lakh chemists across the country to sell the drug and comes at a time when, according to official estimates, over 800 people have lost their lives to the virus in India this year, the highest in the last five years. More than 13,000 others have been infected by the virus so far in 2015. If this shift is carried out, chemists across the country will be able to sell the drug, provided the patient produces a doctor's prescription. They would also have to ensure that details of such sale are recorded in a separate register and maintained for three years.

Members in DTAB meet deliberated that in view of the prevailing situation of alarming surge in swine flu cases this year, fresh notification for the sale of the drug as Schedule H1 may be issued which would enhance availability of the drug in the country. Experts believe that this drug has been in use in the developed countries for years now and there is no compelling evidence to cite that such resistance can develop so quickly. Moreover under Schedule H1, its usage can be closely monitored.

The drug, however, will not be available over the counter. Schedule H1 category was introduced in the drug law in 2013 to combat concerns of antibiotic resistance. The list contains third and fourth generation antibiotics, select habit forming drugs and anti-TB medicines, and mandates the chemist to not only sell it against a prescription but preserve details like name and address of the prescriber, name of the patient, name of the drug and the quantity supplied for three years. Unlike this, to sell drugs clubbed under Schedule X (under which oseltamimir phosphate is classified), the chemist needs a special licence, besides maintaining records of every unit sold for at least two years.

Dr G N Singh, DCGI informed Pharmabiz, "State drug controllers have been asked to issue Schedule X restrictive licences if required. It has to be borne in mind that panic -stricken patients refrain from taking medicines in an irrational way. We are currently recommending Tamiflu for patients who get infected with H1N1 virus." Tamiflu has so far been tightly regulated to prevent its incessant use, which could make the virus immune to the drug.  

The distribution of Schedule X licence holder pharmacies across states and districts is uneven. Besides Swiss innovator Roche, several leading domestic pharma companies such as Cipla, Hetero and Strides Arcolabs produces oseltamivir.

The DTAB after deliberations agreed that Gazette notification issued on September 15, 2009 under the Drugs and Cosmetics Act under Section 26 B may be withdrawn permitting the sale of the drug with conditions as applicable for Schedule H1 drugs and the notification may be issued. While  Schedule H1 may also be amended accordingly.