The Indian Pharmacopoeia Commission with a great degree of autonomy will start functioning from Ghaziabad soon. The details of the structure and functioning of the IP Commission is being currently worked out, according to Dr.Nitya Anand, chairman of the IP Committee.
Speaking on “New directions to IP” at the 7th two day IDMA-APA Pharmaceutical Analysts’ Convention jointly organized by Indian Drug Manufacturers’ Association and European Pharmacopoeia Commission today he said that decision to have an independent IP commission was taken by DTAB as early as 1982. And the Union health ministry cleared the proposal in August 2001.
But on account of various reasons, formation of IP Commission got delayed making regular updating of Indian Pharmacopoeia a difficult task. However the current IP Committee with 19 members has been able to modify IP to a great extend, Dr.Nitya Anand said.
Talking about the latest edition of Indian Pharmacopoeia published in 1996, he said that IP 1996 contains a total of 1149 monographs which include all anti TB drugs and anti AIDS drugs manufactured in India. Of these 42 monographs were added in 2000 and 70 were added in 2003.
Dr.Nitya Anand said that there is need for harmonization of Indian Pharmacopoeia with international pharmacopoeias but at the same time IP should have its own identity as India has a number of herbal drugs and medicinal plants.
IP Commission will have some new tasks now in the coming years with the changes taking place in patent laws and other regulatory requirements. An important addition to the IP will be fixed dose combinations of drugs for infectious diseases like TB and AIDS. He said that fixed dose combinations of drugs are an accepted therapeutic modality of treatment for these diseases. It is also important to incorporate monographs of all drugs required for public health irrespective of their patent status, he said.
Earlier Dr.Y.K.Hamied, chairman of Cipla said that Indian pharmaceutical industry has grown from a small producer of drugs worth hardly Rs.10 crore in 1947, to a leading world producer of quality drugs and pharmaceuticals valued at Rs.20,000 crore. This is the beginning of a golden age of Indian pharmaceutical industry. Indian drugs labels are no more unacceptable in the developed markets.
This growth and international recognition has been possible with the strict adherence of high standards of manufacturing adopted by the Indian companies over the years. It is extremely important to ensure higher quality standards to have safety and efficacy of each pharmaceutical product. And for this in process control checks are most crucial at every stage of manufacturing.