In the last three weeks, the Tamil Nadu Drugs Control Department has granted approvals to as many as 15 pharmaceutical units across the State for the manufacture of hydroxychloroquine (HCQ) tablets.
Officials of the Health Department said the 15 units, which had applied for permission to manufacture the tablets, were given the nod in a day. A bulk drug manufacturer in Hosur had also sought approval, which was granted the same day.
“The government has declared that the conditions for Schedule H1 drugs will apply to HCQ tablets. The role of the Drugs Control Department is to see to it that the drug is sold as per Schedule H1 conditions. This means pharmacists should maintain a separate registry for the sale of HCQ and should sell it only based on the doctor’s prescription. Schedule H1 includes antibiotics and anti-tuberculosis drugs,” an official said.
Once these manufacturers get the approval for production, they can place orders for the supply of Active Pharmaceutical Ingredients, i.e., the raw materials, he said.
As of now, there is a minimal stock of HCQ in districts across the State. Doctors are not prescribing the drug to people, officials said.
J. Jayaseelan, chairman, Indian Drugs Manufacturers’ Association, Tamil Nadu, said the country had an adequate quantity of the anti-malarial drug, and there was no chance of stocks running out. “Tamil Nadu has not started prescribing the drug as a prophylactic. Even if it does, the State government will be in a position to buy the drug easily,” he said.
The Centre had fixed the price of HCQ, he said, adding, “The rate - Rs. 5.80 for a 200 mg tablet - is below the MRP. The raw materials cost more, and hence, many are unable to manufacture the drug immediately. Pharmaceuticals are in the ‘essentials’ category. As of now, there is restricted manufacturing, and about 25% to 30% of our capacity is functional. However, we will have enough drugs considering the capacity of leading manufacturers in the country.”
He said India was the main supplier of HCQ to the world, and barring one or two components, all the raw materials were manufactured here.
