After substandard drug manufacturing, the state drug firms are once again under the scanner of the central government for manufacture and sale of unapproved fixed dose combination (FDC) drugs which are categorised as new drugs and require central approval.
Since such drugs pose a potential risk to public health and safety, the Drugs Controller General of India (DCGI) has directed the state drug authority to prevent manufacture, sale and distribution of 26 such drugs found manufactured by 19 drug firms from Baddi, Solan, Paonta Sahib and Kangra.
These also comprise five drug samples manufactured by a Baddi-based firm while two each are manufactured by three other firms from Paonta Sahib, Baddi and Kangra.
These FDCs are assigned to treat common ailments like cough, hair loss, pain, diabetes, vitamin deficiency, nerve pain, fluid retention, asthma and acid indigestion.
A list of 90 such drugs which are being readily sold in the market and manufactured in various states without the requisite central approval has been circulated to the respective states.
The central authorities noted that “the presence of new drugs in the supply chain is a matter of serious concern posing potential risk to public health and safety. It also indicates non-compliance with the provisions of the Drugs and Cosmetics Act, 1940.”
The state drug authority has been directed to examine whether the listed unapproved FDCs have been granted approval by them.
In case the requisite approval has not been sought from the central regulator, the state authority has been directed to prevent their manufacture, sale and distribution.
The safety and efficacy of the FDCs has been a contentious issue with the DCGI directing the manufacturers from time to time to submit clinical data to establish their safety and scientific rationale. FDCs are essentially medicines that combines two or more active drugs in a single dosage form such as tablet or capsule.
Earlier, 80 FDCs were banned by the central government in January 2019 while the National Pharmaceutical Pricing Authority (NPPA) had expressed its concern that approval of these FDCs may compromise the rationale in the usage of the drugs and may lead to over-medication.
“We have asked the manufacturers to submit the permissions taken for manufacturing these FDCs as it is mandatory under Rule 83 of the New Drugs and Clinical Trials (NDCT) Rules, 2019,” informed State Drugs Controller Dr Manish Kapoor.
This rule mandates that manufacturers must obtain permission for a new drug from the central licensing authority (DCGI) before applying for a manufacturing licence. The drug authorities have been directed to submit action-taken report to the DCGI.
