**Executive Summary:**
This order, issued by the Drugs Controller General of India on May 1, 2017, addresses the import of Technetium 99 Generators, used in the diagnosis of cancer and cardiovascular diseases. It allows a 45-day period for import of these generators while applications for registration certificates are under consideration. Importers must submit samples for testing within 10 working days of the order's issue.
**Key Points / Main Content:**
* **Import of Technetium 99 Generators:**
* Import of Technetium 99 Generators permitted for 45 days from May 1, 2017, for importers with pending registration certificate applications.
* This is to ensure uninterrupted supply for diagnosis of critical diseases.
* **Testing Requirements:**
* Importers must provide a sample of each manufacturer's Technetium 99 Generator for testing to either Radiation Medicine Centre of BARC or Institute of Nuclear Medicines Allied Sciences INMAS within 10 working days of the order.
* Importers are responsible for obtaining necessary permissions from AERB to transport samples.
* **Consequences of Test Failure/Non-Compliance:**
* If a sample fails testing, imports from that manufacturer will be prohibited, and existing stocks must be disposed of or re-exported.
* Failure to submit samples within 10 working days results in immediate import prohibition.
* **Post 45-Day Period:**
* No imports allowed after 45 days from May 1, 2017, without valid registration.
**Impact Analysis:**
* **Importers:**
* *Impact:* Can continue importing Technetium 99 Generators for 45 days while registration is pending, provided they comply with testing requirements. They face potential import bans and disposal requirements if samples fail.
* *Action Required:* Submit samples for testing within 10 working days, seek AERB permission for transport, and ensure registration is completed within 45 days.
* **Radiation Medicine Centre of BARC and Institute of Nuclear Medicines Allied Sciences INMAS:**
* *Impact:* Responsible for testing Technetium 99 Generator samples.
* *Action Required:* Test samples provided by importers.
* **CDSCO Port Offices:**
* *Impact:* Responsible for enforcing the order and ensuring compliance at ports.
* *Action Required:* Monitor imports, verify sample submissions, and enforce import restrictions based on test results and registration status.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: Indian legislation regulating the import, manufacture, and sale of drugs to ensure their safety, efficacy, and quality. It is a key law referenced in the context of import regulations.
Drugs and Cosmetics Rules, 1945: Rules specifying the provisions for grant of Registration Certificate and Import License for import of Drugs including Radiopharmaceuticals as per the Drugs and Cosmetics Act, 1940.
CDSCO: Central Drugs Standard Control Organization. The national regulatory body for pharmaceuticals and medical devices in India, responsible for regulating the import of drugs.
DCGI: Drugs Controller General of India. The head of the Central Drugs Standard Control Organization (CDSCO) responsible for approving licenses of specified categories of drugs.
BARC: Bhabha Atomic Research Centre. An Indian nuclear research facility involved in the context of obtaining NoC for end users importing Radioimmuno assay Kits and tracers.
Radiation Medicine Centre of BARC, Mumbai: A testing center for radiopharmaceutical products located in Mumbai, Maharashtra, which importers were expected to use for testing Technetium 99 Generators.
Institute of Nuclear Medicines Allied Sciences INMAS, Delhi: A testing center for radiopharmaceutical products located in Delhi, which importers were expected to use for testing Technetium 99 Generators.
Technetium 99 Generators: Generators used to produce Technetium-99m, a radioisotope used in nuclear medicine for diagnostic imaging. The document addresses issues related to their import.
FILE No. DCG(I) /MISC/2017(11)
DIRECTORATE GENEAL OF HEALTH SERVICES
OFFICE OF DRUGS CONTROLLER GENERAL (INDIA)
(IMPORT & REGISTRATION)
ORDER
Date 01.05.2017
WHEREAS, in terms of sub clause (1) of clause (b) of section 3 of the Drugs and
Cosmetics, Act 1940, import, manufacture and sale of drugs is regulated with a view to
ensure their safety, efficacy and quality;
AND WHEREAS Rules 23 to 27(A) of the Drugs and Cosmetics Rules, 1945 specify
the provisions for grant of Registration Certificate and Import License for import of Drugs
including Radiopharmaceuticals;
AND WHEREAS vide letter No. 1/RIA(NOC)/2003-DC dated 6" Feb. 2006, it was
clarified that this Directorate had no objection for importing various Radioimmuno assay
Kits and tracers so far as the provisions of the Drugs and Cosmetics Act, 1940 and rules
thereunder were concerned, subject to the condition that before importing these kits, the
importer would obtain NoC from BARC for the end user and the same shall be submitted
to the Customs Authorities at the time of import;
AND WHEREAS in response to the clarification sought by the CDSCO Port Office,
CDSCO Hars vide letters No. Import/Misc./78/2016-DC dated 12% Sept. 2016 and 13%
Oct. 2016, informed all port offices of CDSCO that Radiopharmaceutical products or
Radioimmunoassay Kits are required to be regulated under provisions of the Drugs and
Cosmetics Act and Rules thereunder and that no consignment of such products may be
released without import license;
AND WHEREAS aggrieved by the decision, a number of representations were
received by CDSCO and, thereafter, a meeting of importers and experts in the field of
nuclear medicines was convened on 7* Nov. 2016 in DCG(I)’s chamber to resolve issues
pertaining to import of such products;AND WHEREAS vide letter No. 29/Misc/4//2016-DC(101) dated 29.12.2016,
stakeholders were informed that a transition period of 45 days has been given to
importers to submit application for grant of import license;
And whereas some applications were received through the online portal and after
scrutiny of the applications, the deficiencies were pointed out and queries sent to the
applicants;
AND WHEREAS the applicants have failed to submit the requisite clarifications
despite lapse of a considerable time;
AND WHEREAS issues relating to import of radiopharmaceutical products/ radio-
Immuno assay kits for (in-vivo or in- vitro) diagnostics use had been further examined in
the light of the provisions of the Act and Rules thereunder and it had been decided that:
i. For those in-vivo radiopharmaceutical products, which do not have
indigenous manufacturing facility, Form -10 license may be granted after
approval of the Central Government, without Registration Certificate under
Rule 24 (2) second proviso.
Those in-vivo radiopharmaceuticals for which indigenous manufacturing
facilities are available, import registration and license in Form 10 will have to
be obtained as per provisions of the Drugs and Cosmetics Rules, 1945 and
such products shall be tested for their quality at the time of import.
AND WHEREAS it has subsequently been informed by the importers that Radiation
Medicine Centre of BARC or Institute of Nuclear Medicines & Allied Sciences
(INMAS), Delhi have not accepted the samples for testing and also stated that
necessary permission may also be required from AERB for transporting such
samples to the testing centres;
AND WHEREAS various representations have been received from importers
stating that they have stopped import of Technetium 99 Generators as they are not
able to comply with the condition relating to testing stated in the Notice No.
DCG(I)/Misc/2017(21) dated 20.02.2017;
2AND WHEREAS representations have also been received from different
Associations of Physicians stating that various directions issued by CDSCO should
not result in disruption of routine functioning of Nuclear Medicine Centers and also
suggested to have dialogue with Radioactive import vendors and Nuclear Medicine
physicians to find a lasting solution to this problem;
NOW, THEREFORE, after careful examination of the matter and to facilitate
an un-interrupted supply of Technetium 99 Generators and noting that these
generators have continued to be imported for quite some time, it has been decided:
to permit import of Technetium 99 Generators by importers, whose
applications are under active consideration of this Directorate for grant of
registration Certificate for a further period of 45 days from the date of issue
of this order as these products are to be used in the diagnosis of cancer and
cardiovascular diseases and their inadequate availability could hamper public
health.
that the importer shall voluntarily make a sample of Technetium 99
Generator available for test and analysis by Radiation Medicine Centre of
BARC or Institute of Nuclear Medicines & Allied Sciences (INMAS) from out
of the samples imported within 10 working days of this order in respect of
each manufacturer.
that necessary permission may be sought by importers from AERB to
transport the sample of Technetium 99 Generators to testing centre.
that in cases, where the samples fail in test/analysis, no imports from the
manufacturer shall be permitted and stocks already imported or in transit
shall be disposed of or re-exported in the prescribed manner.
in other cases, import shall be permitted pending completion of all formalities
for registration for a period not exceeding 45 days from the date of this order
subject to the condition that the sample manufactured by the manufacturer
concerned has been submitted within the stipulated timeframe for testing.vi. In case of non-submission of sample for testing/manufacturing within 10
working days by the importer in respect of the product or a manufacturer,
no import shall be allowed.
vii. No import shall be allowed after 45 days from the date of this order without
valid registration.
(Dr. G.N. Singh)
Drugs Controller General of India
To,
Ne All concerned importers
All port offices of CDSCO
CC:
AWNe The Director, Radiation Medicine Centre of BARC, Mumbai
The Director, Institute of Nuclear Medicines & Allied Sciences (INMAS), Delhi
PPS to DG(DGHS), Nirman Bhavan, New Delhi
PPS to JS(KLS), Nirman Bhavan, New Delhi