The Bangalore District Chemists and Druggists Association (BDCDA) has come with a demand urging the Union government to withdraw the order dated March 10 prohibiting manufacture, sale and distribution of 344 fixed dose combinations in the country.

The Association has conveyed to the government that it would be more prudent to reconsider the Expert Committee in the interest of the public and the pharma trade.

In its notification, the government stated that these 344 drugs are likely involve risk to human beings and also found to have no therapeutic justification. Now these statement from the government has raised serious questions as 344 FDCs were used by scores of patients with no reports of adverse drug reaction (ADR), fatality and risk, said V Harikrishnan, president, Bangalore District Chemists and Druggists Association.

In 1980, the Drugs Consultative Committee formed a sub-committee of experts to screen formulations from the point of therapeutic rationale to prohibit harmful combinations and this was approved by the ministry of health and family welfare. Section 10A, 26 A and 33 EED have been inserted in the Drugs & Cosmetics Act by amending Act 68 of 1982 allowing the government to prohibit sale of drugs which do not have therapeutic value and risky for humans.

Under Section 26 A of the D&C Act, the government initially prohibited sale of 12 drugs including FDCs. Over a period of 33 years, it banned 94 drugs. BDCDA is of the view that the ban of 344 drugs should have been done in consultation with DTAB giving scope for a judicial review, he added.

Now the Association questions how the government could ban 344 drugs without a judicial review. It points out the instance where the Madras High Court disposed a writ petition filed by Cipla and others challenging the ban on Phenylpropanolamine and other formulations. The court stated that Section 26A cannot be read in isolation but should be read with Section 5 A which makes it mandatory to take advice of DTAB before any decision is taken.

Harikrishnan, pointed out that notification under Section 26 A also prohibited manufacture and sale of corticosteroid FDCs for asthma treatment although it was not violating of Article 19(1) of the Constitution, Sytopic Labs versus Prem Gupta 1984 Supp(1) SCC 160. Prior to this impugned ban, notification was issued based on an ADR report either in India or other countries.

“It now appears that this ban order is the result of non-submission of safety and efficacy data by the pharma companies. It is mainly a licensing issue. If the manufacturer has not submitted the required documents, the government would have resorted to an administrative action such as product suspension rather banning drugs available for over 25 years in the country. DCGI had also suggested that in case of ADRs, companies could highlight the same in a ‘box warning’,” he said.

The two government committees under late Prof Ranjit Roy Choudhary and Prof CK Kokate advocated clinical trails on Indian population, post marketing surveillance for FDCs besides formulate guidelines for functioning of New Drug Advisory Committee for FDCs. It also stated that if the government viewed drugs were risky for human use, safer alternatives should be made available.

“We request the government to clarify if there are any ADRs with these 344 FDCs and also indicate who could withdraw the drugs which are already purchased by consumers. Patients do not purchase the FDCs as per their judgments but are prescribed by registered medical practitioners who recommend branded formulations. Therefore, this ban of 344 drugs is creating an acute shortage of medications for cardiac, diabetic, asthmatic and psychiatric patients. Therefore, the government should immediately look to reverse the ban because there are no ADRs reported so far,” said Harikrishnan.