Even as the offices of the national drug regulator (DCGI) and of the state regulatory bodies are silent over enforcing the Gazette Notification of March 10 this year due to various court orders, the New Delhi based Federation of Indian Pharmacists’ Organisations (FIPO) has urged the Union health secretary to take measures to ensure foolproof enforcement of the notification which prohibited manufacture and sale of 344 fixed dose combinations for human use.
 
Stating that compliance of gazette notification is the bounden duty of both the regulators and traders/manufacturers, the Federation wanted the health ministry to make public the action taken reports of the DCGI and of the state enforcement agencies on the ban order, since the notified date of March 10.
 
Urging the government to delete all the 344 combination drugs from hospital formulary and also from the lists of medicines of central and state health departments, Dr R S Thakur, president of FIPO has wanted the government to encourage the state drugs controllers to set up Special Task Forces (STF) for this purpose and make the daily report public. His letter says that an online or written reporting system has to be developed by healthcare providers and public if any of these 344 products are prescribed, dispensed, sold or administered to patients.
 
“It is now seven weeks have passed since the notification has come hence it is necessary to take stock of the situation. The authorities have to ensure complete weed out of all the banned products from the warehouses of distributors, godowns of C&Fs, store houses of wholesalers and retailers, medical store depots of central and state governments, hospital pharmacies, nursing homes and from private clinics of doctors, including physician’s samples, so as to comply with the notification. The authorities should ensure complete destruction of all the stocks, so that their clandestine use can be stopped,” he told Pharmabiz over telephone.
 
FIPO wants the Union government to cancel the licences of the manufacturers in respect of the banned FDCs, as PART- VII of the Drugs and Cosmetics Rules 1945 and Form 25 thereof are silent about automatic cancellation of licences if any endorsed product is prohibited under Section 26 A of the D&C Act 1940. Hence it is desirable to delete all such endorsements in Form 25.
 
Pointing out that it is government responsibility to give prime importance to the health and happiness of the people, Dr Thakur quoted a pronouncement of the chief justice of the US Supreme Court, way back in 1970 in a similar case related to FDC drugs, who said “commercial success alone does not constitute substantial evidence of drug safety and efficacy.”
 
The copies of the letter, signed by Dr Thakur and sent to the Union health ministry, have been sent to all the state regulators and to the Drug Controller General of India. It says that awareness classes about the banned products should be conducted in cities and villages to educate the doctors, dentists, pharmacists, nurses, wholesalers and retailers about the ban and its compliance.