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DTAB refuses to revoke ban on FDC of vitamin B1, B6 and B12
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Gireesh Babu, New Delhi
June 29 , 2023
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The Drugs Technical Advisory Board (DTAB) has refused to revoke the prohibition on the use of the fixed dose combination (FDC) of vitamin B1, B6 and B12, as against a representation from a multinational pharmaceutical company in the country, noting that the justification and documents are not adequate for revocation of the ban.
The Board meeting held recently considered the representation from the firm requesting to reconsider the lifting off of the prohibition of manufacture, sale or distribution of the FDC, on the grounds that as science has advanced, other levels of quantitative composition of vitamin B1, vitamin B6 and vitamin B12 have been studied.
It has requested the ministry of health and family welfare and the Central Drugs Standard Control Organisation (CDSCO) to lift the ban and open to evaluate the FDC with different quantitative compositions for their specific indications. There are ample published clinical studies which support the fact that the FDC has strong therapeutic rationale. According to the minutes of the DTAB meeting, the representation was submitted by multinational healthcare firm P&G.
The firm also stated that many clinical studies were conducted using different quantitative levels of FDC for various indications such as vitamin B deficiencies, neuropathy of different etiologies such as diabetes, repetitive stress or trauma like in carpal tunnel syndrome, alcohol abuse, autoimmune diseases like rheumatoid arthritis, chronic inflammation and calculates, and other diseases affecting the nervous system.
It also informed that products with different levels of FDC of neurotrophic vitamins such as B1, B6 and B12 have been marketed for more than 50 years worldwide and are well established and extensively used in clinical practice. It is available mainly over the counter (OTC), but also on prescription depending on vitamin strengths and application route by several marketing authorisation holders. The company said that it has received approval from countries like Hungary, Czech Republic and Indonesia with the same formulation and the same indication.
“DTAB deliberated the matter and opined that the justification and documents are not adequate for revocation of prohibition of manufacture, sale or distribution of the fixed dose combination of vitamin B1, vitamin B6 and vitamin B12 and therefore the Board did not agree for revocation,” said the minutes of the meeting.
The FDC was earlier manufactured and marketed in the oral as well as injections form for indications like neuropathy, in the country. However, it was banned in India through a notification on October 14, 199 with effect from January 1, 2001, on the basis that the FDC did not have therapeutic value claimed or purported to be claimed for it.
A clarification was issued by the Drugs Controller General (India) (DCGI) in January 2000, that the ban is only on the manufacture, sale or distribution of combination of vitamin B1, vitamin B6 and vitamin B12 and does not cover other multivitamin preparations having B-complex drugs of vitamins.
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