23 July 2009
The physicists have designed the “hot laboratory” in the institution following the specifications received from USA. They started radioisotope studies in 1951. The institution imported radioisotopes such as P-32, from Harwell, England. Incidentally, Dr Homi Bhabha organized this national conference at the suggestion of Pandit Jawaharlal Nehru who wanted that this opportunity may be used to review what has been done in the field of atomic energy till then. Over 100 specialists attended the meeting. The medical use of radioisotopes grew progressively with the commissioning of Apsara reactor in 1956. Besides diagnostic applications, the specialists started using radioisotopes such as iodine-131 and phosphorous-32 in radiotherapy. During early sixties, test monographs for a few radiopharmaceuticals appeared in international pharmacopoeia and in those of some countries. According to the reports available with the Radiopharmaceuticals Division, Bhabha Atomic Research Centre, the Drug Control Administration in India considered to clear radioisotopes under licence number 720. Uses of reactor- produced radioisotopes increased rapidly. They were in diverse form such as ready-to-use preparations for oral use and for use as injectables; short-lived radioisotope generators to prepare ready-to-use organ imaging agents by intravenous use; cold kits amenable to instantaneous and quantitative incorporation of short-lived radioisotopes for organ imaging etc.
-by Dr K S Parthasarathy
Early History of Nuclear Medicine in India
-by Dr K S Parthasarathy
It appears that the first reference on the medical use of radioisotopes in India has been by Dr Subodh Mitra former Director, Chitaranjan Hospital, Calcutta. In a paper titled “Health Protection, and Biological and Medical Applications of Atomic Energy” (Proceedings of the Conference on development of atomic energy for peaceful purposes in India, Nov 1954), he reviewed the radioisotope- related work in his institution.
The physicists have designed the “hot laboratory” in the institution following the specifications received from USA. They started radioisotope studies in 1951. The institution imported radioisotopes such as P-32, from Harwell, England.
Incidentally, Dr Homi Bhabha organized this national conference at the suggestion of Pandit
Jawaharlal Nehru who wanted that this opportunity may be used to review what has been done in the field of atomic energy till then. Over 100 specialists attended the meeting.
The medical use of radioisotopes grew progressively with the commissioning of Apsara reactor in 1956. Besides diagnostic applications, the specialists started using radioisotopes such as iodine-131 and phosphorous-32 in radiotherapy.
During early sixties, test monographs for a few radiopharmaceuticals appeared in international pharmacopoeia and in those of some countries.
According to the reports available with the Radiopharmaceuticals Division, Bhabha Atomic Research Centre, the Drug Control Administration in India considered to clear radioisotopes under licence number 720.
Uses of reactor- produced radioisotopes increased rapidly. They were in diverse form such as ready-to-use preparations for oral use and for use as injectables; short-lived radioisotope generators to prepare ready-to-use organ imaging agents by intravenous use; cold kits amenable to instantaneous and quantitative incorporation of short-lived radioisotopes for organ imaging etc.
The specialists in this field realized from the very beginning that the production, testing and supply of radiopharmaceuticals must fulfil medicolegal aspects related to the manufacture and use of conventional drugs and radiological safety requirements.
With regulatory control in mind, scientists in the Department of Atomic Energy established a radiopharmaceutical committee and a nuclear medicine committee.
These committees covered all aspects related to the safety of premises, products, patients, workers and the public. Director, BARC set up the Radiopharmaceutical Committee on February 23, 1968. The seven-member committee had Dr V.K.Iya then Head, Isotope Division and, a pioneer in the field as its convener.
The other members of the committee Dr R.S.Mani, Shri T.S.Murthy and Shri N.G.S.Gopal all from Isotope Division were eminently qualified specialists. Since radiopharmaceuticals have to satisfy the general requirements of conventional drugs, the committee had a representative from the Directorate General of Health Services (DGHS), Government of India, as a member.
The committee was to examine the production, practices, controls and the specifications of the radiopharmaceuticals supplied by the Isotope Division and also to consider and recommend the incorporation of radiopharmaceuticals into the Indian Pharmacopoeia.
Simultaneously, Director, BARC set up a five member Nuclear Medicine Committee with members drawn from BARC (Medical Division, Isotope Division, Radiation Medicine Centre), Directorate of Radiation Protection, and the Directorate General of Health Services, Ministry of Health, Government of India, Delhi.
The Committee evaluated the proposals for research, diagnostic and therapeutic uses of radioisotopes, approved a list of doctors trained in radioisotope techniques for established diagnostic and therapeutic procedures, developed procedures for giving standing clearances to established doctors for using standard products without delay and examined applications from every new user and for every new use of medical radioisotopes.
Another function of the nuclear medicine committee was to establish jointly with radiopharmaceutical committee procedures for the release of new products by the Isotope Division, BARC, for medical use.
These Committees were periodically reconstituted. When The Department of Atomic Energy set up the Board of Radiation and Isotope Technology (BRIT), the reconstituted Radiopharmaceutical Committee was brought under it. The Members of the Committee included specialists in nuclear medicine and pharmacy, Commissioner, FDA or his nominee and Drug Controller (India) or his nominee.
These committees met as frequently as necessary. These procedures assured overall though it may be difficult to find direct legal basis for their activities.
In 1977, the Director General of Health Services, Government of India notified that “radiopharmaceuticals” are exempt from the provisions of Chapter IV of the Drugs and Cosmetics Act 1940.
Many considerations must have contributed to this. The mass of radioactive material in any radiopharmaceutical is too trivial to cause any toxic effect; the normally used radioactive materials such as Tc-99m have very short half-lives; it may not be feasible to study them for sufficiently long periods to evaluate the relevant parameters as is done for conventional pharmaceuticals.
During the early sixties and seventies, BARC was the only agency preparing radio pharmaceuticals. In light of interactions with the specialists in BARC, the officials of the Directorate General of Health Services must have realized that granting exemptions will not have serious consequences. DGHS gave exemption nine years after the formation of the Radiopharmaceuticals Committee in which DGHS also had representation.
The Central Government set up the Atomic Energy Regulatory Board (AERB),to enforce safety provisions under the Atomic Energy Act 1962.
AERB reviewed the procedures followed for ensuring safety in the medical use of radioisotopes and retained the set up. In order to provide the much needed legal basis for carrying out medical radiation procedures safely, AERB issued Radiation Surveillance Procedures for Medical Applications of Radiation, 1989 exercising the powers vested under Rule 15 of the Radiation Protection Rules 1971.
As required in the Surveillance procedures, the Board issued several codes; one of them applied to nuclear medicine procedures.
With about 200 physicians licensed to practice nuclear medicine in the country, the facilities available are very modest. Just over 150 hospitals located mainly in cities provide the service.
The field is changing rapidly. The setting up of seven cyclotrons which serve several centres is a notable development.
India needs a ten-fold increase in facilities and man-power to ensure that its population derives the benefits from this advanced field of medicine.▄
