The Union health ministry will soon bring the phyto pharmaceutical sector under the Drugs and Cosmetics Act (D&C Act) to streamline the sector which at present remains by and large unregulated in the country.
According to sources, the matter related to the phyto pharmaceutical sector came up for discussion at the recently held Drugs Technical Advisory Board (DTAB) meeting. After detailed deliberations, the meeting decided to bring the phyto pharmaceutical sector under the D&C Act. The Drugs Controller General of India (DCGI) has been empowered to take immediate steps to bring the sector under the D&C Act.
Phyto pharmaceuticals are the pharmaceutical products which are sourced through plants. At present, the sector is not covered by any regulation which has resulted in utter chaos prevailing in the sector. For quite some time, the Phyto pharmaceuticals industry in the country has been demanding to bring the sector under regulation to streamline it.
The newly constituted DTAB, which is the highest decision-making body under the union health ministry on technical matters, held its first comprehensive meeting on October 10 under the chairmanship of Director General of Health Services (DGHS), who is the ex-officio chairman of the Board.
There are 18 members in the newly constituted DTAB whose term is for three years. Other members of the DTAB include DCGI Dr Surinder Singh; director of Central Drug Laboratory (Kolkatta) Dr P K Guha; director of Central Research Institute (CRI), Kasauli; director of Indian Veterinary Research Institute (IVRI), Bareilly; president of Medical Council of India (MCI); president of Pharmacy Council of India (PCI); and director of Central Drug Research Institute (CDRI), Lucknow.
There are two members in the DTAB who are nominated by the DCGI. They are Karnataka drug controller Dr Jagashetty and Jammu & Kashmir drug controller Satish Gupta. K Chinnaswamy is the other member of the Board who was nominated by the PCI. The MCI has named Dr Dhorubajyat Bora as its nominee in the Board. Dr BPS Reddy, CMD of Hetero Drugs, is the nominee of the pharma companies.
Other members of the 18-member Board include: Dr FD Seth, advisor to Clinical Trial Registry of India (CTRI); Dr Dharam Prakash, nominee of India Medical Association (IMA); Dr C Gopalakrishna Murthy of Indian Pharmaceutical Association (IPA); and two govt analysts—J K Raj Vaidya of Drug Testing Laboratory, Madhya Pradesh and Yatendra Raj Mehta of drug testing laboratory, Rajasthan.