Even as a section of drug manufacturers in India have secured a stay from the Madras high court against the government move to ban combination drugs licensed by state drug regulators without proper quality safety tests, the 500,000-plus retail pharmacies in the country have decided to stop purchases and sale of these controversial drugs from this week onwards.
About 500,000 retail pharmacies have decided to stop purchases and sale of the controversial drugs from this week
This follows a decision by the country’s largest chemists and druggists association—the All India Organization of Chemists and Druggists (AIOCD)—to boycott the sale of these 3,000-odd drug brands in the wake of the Central regulator’s recent directive to withdraw licences of all such drugs.
AIOCD currently represents more than two-thirds of the total 580,000 drug wholesale and retail outlets in the country.
AIOCD president J.S. Shinde said, “We have unanimously decided to stop trading of these combination drugs, which are not fully complied with the government’s quality norms, immediately. Though the decision is in the larger interest of the public health, we also fear that an imminent withdrawal of these drug brands from the market will cause a huge inventory pile-up at the pharmacies as well as the distribution points.”
“The retail and wholesale trade has a stock of Rs600-800 crore of such products at present. This stock will be returned to the companies, though our members in the rural and remote areas have been given three months’ time to do so,” Shinde added.
Currently, these combination drugs account for more than 10% of the total Rs30,000 crore worth drugs sold in the country through retail pharmacies in a year. Jayesh Mehta, a Mumbai-based retail chemist and an active member of the trade association, said, “Since many of the Mumbai-based drug makers have already recalled their combination brands, there has been a cut in sales though the inventory in the purchase pipeline remains a concern.”
Combination drugs are made by combining two or more existing drugs in a single formulation such as tablet, capsule or oral solution.
These formulations were launched by drug companies as?new?brands,?on?the pretext of remedies for multiple diseases, with manufacturing and marketing licences from the state drug regulators. As reported by Mint earlier, the drug controller general of India had, in October last year, asked all the sate regulators to withdraw these licences as the safety and efficacy of such drugs were not adequately tested.
But the trade decision to stop fresh purchases has created a new challenge for drug makers who are yet to withdraw their combination brands. Although industry association Confederation of Indian Pharmaceutical Industry, which largely represents small and medium drug makers, secured a court stay against the government’s move to cancel licences of combination drugs, they will now find it difficult to sell these brands.
Meanwhile, the drug controller general has filed a counter-affidavit in the Madras high court, justifying the government’s stand to pull out these brands from the market on account of patient safety, to get the stay vacated. The court is expected to take up the counter-affidavit this week.
Since the court stay against the drug regulator’s order to cancel the combination drug licences is applicable mainly in the states of Tamil Nadu, Karnataka, Andhra Pradesh and Puducherry, the state authorities are not in a position to implement the Central order. But several of the large and medium drug makers have stopped manufacturing these drugs and have applied for fresh licences as per the Centre’s new directive.
India’s drug controller general M. Venkateswarlu in an earlier interview had said that his department had received about 186 new applications for approval of combination drugs and 50 out of this have already been rejected due to inadequate documentation to prove quality and efficacy.
“I am happy that the trade association has confirmed that it will support the government move to arrest circulation of poor quality drugs in the market, though we are just waiting for the Madras high court ruling on our counter-affidavit to get the stay vacated to go ahead with the decision, which is part of regularizing the drug licensing system in the country, and also weed out unsafe drugs from the market,” said Venkateswarlu in a telephone interview on Sunday.