The phytopharmaceutical industry in the country has asked the union health ministry to take into consideration its concerns before amending the Drugs and Cosmetics (D&C) Rules to insert separate definition for phytopharmaceutical drugs and also for its inclusion in the definition of new drug.
The country has rich heritage of numerous phytopharmaceutical drugs and one of the significant exports from India is herbal extracts. A number of Indian manufacturers manufacture and export herbal extracts under the ambit of phytopharmaceutical drugs which are now sought to be brought under the proposed draft rules.
The proposed rules require data to be submitted along with the application at par with the ‘chemical drugs’. But the industry rues that the data required is exhaustive which may not be available for the ancient ayurvedic or herbal extracts products.
As per part two of the proposed rules, the industry has to generate extensive data including taxonomical information along with the certificate issued by a qualified taxonomist and chromatographic fingerprints of the samples. Besides, the safety and pharmacological section mandates animal toxicity and safety data like oral toxicity, geno toxicity, dermal toxicity and teratogenicity study.
The ministry’s proposed draft rule clearly indicates that as per the proposed rules the phytopharmaceutical drugs are being treated at par with chemical drugs. But the industry expressed its concern to the ministry that due to its complex nature, it may not be possible to make available or generate all the data as required in the proposed rules.
Asking the ministry to consider different set of guidelines for phytopharmaceutical drugs, the industry pointed out that global regulatory authorities like Health Canada has a separate division called Natural Health Product Directorate for regulating phytopharmaceutical drugs. Likewise, TGA Australia also has different guidelines for herbal products.
Welcoming the ministry’s initiative to regulate the phytopharmaceutical drugs, the industry however said that the proposed rules must reflect the present capability of industry and should be benchmarked with the current global practices. The adoption of draft rules in its present form will adversely impact the export of herbal extracts from India, the industry cautioned the ministry.