The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Ministry of Health and Family Welfare, issued a notice on October 6, 2016, outlining ongoing efforts to streamline activities under the Drugs and Cosmetics Act, 1940, and Rules, 1945.
Recent measures include: facilitating import clearance via ICEGATE; online submission and processing of various applications through the SUGAM portal (including import registration/licensing of drugs and medical devices, registration of cosmetics, import permits for personal use, test licenses, Ethics Committee registration, BA/BE NOC for export, online fee payment, and a General Administration Module/Budget Information System); risk-based inspections of drug manufacturing facilities; and training programs for state and central regulatory officials.
In alignment with the "Make in India" initiative, CDSCO is revisiting regulatory provisions under the Drugs and Cosmetics Rules, 1945. Specifically, the organization is considering making the validity of manufacturing, sales, and distribution licenses for drugs and cosmetics, as well as the approval of drug testing laboratories, perpetual unless suspended or cancelled, with compliance assessments at least once every 10 years. Additionally, CDSCO is undertaking a gap analysis and update of Good Manufacturing Practices (GMP) as outlined in Schedule M to align with WHO GMP guidelines.
Stakeholders were invited to provide comments, suggestions, and inputs via email to dci@nic.in by October 21, 2016, for consideration.
Key Entities Referenced
Central Drugs Standard Control Organization: A central regulatory body in India responsible for drug regulation.
Drugs Cosmetics Act, 1940: An act in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs Cosmetics Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for drugs and cosmetics.
ICEGATE: Indian Customs Electronic Commerce Gateway, a portal for electronic filing of import/export declarations.
SUGAM portal: An online portal for submission and processing of applications related to drugs, medical devices, and cosmetics.
Make in India: An initiative by the Government of India to encourage domestic manufacturing and investment.
Schedule M to Drugs Cosmetics Rules, 1945: A schedule within the Drugs and Cosmetics Rules that prescribes Good Manufacturing Practices (GMP) for pharmaceutical products.
WHO GMP: World Health Organization Good Manufacturing Practices guidelines for pharmaceutical products.
No. DCG (1)/Mise./2016 (113)
Central Drugs Standards Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
FDA Bhavan, Kotla Road,
New Delhi-110002.
6th October, 2016
NOTICE
Central Drugs Standard Control Organisation is continuously engaged in streamlining various
activities under the Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder:
2. The organization has already taken various important measures in recent months for streamlining
the following activities:
(i) Import clearance through ICEGATE
(ii) Online submission and processing of following categories of applications through SUGAM portal:
e Import registration and licensing of drugs
Import registration and licensing of medical devices
Registration of Cosmetics
Permit for import of drugs for personal use by patients
Test Licence for import of small quantities of drugs for test and analysis
Registration of Ethics Committee
BA/ BE NOC for Export purpose
Online Facility for payment of fee for various applications
Online General Administration Module — Budget Information System
(iii) Risk Based Inspection of drug manufacturing facilities in the country based on check-list and
evaluation tools developed for the purpose.
(iv) Imparting training to the regulatory officials of States and Centre through various training modules
to improve the quality of services provided by the regulators.
3. Keeping in view the Government of India’s policy to bring ease in doing business for making the
“Make in India’ concept a reality, CDSCO is in the process of revisiting the following regulatory
provisions under the Drugs & Cosmetics Rules, 1945 to further improve the quality of services provided
by the drug regulatory authorities of the States and Centre:
|. Validity of various licences/approvals granted under the Drugs & Cosmetics Rules, 1945 for
manufacture for sale, sale and distribution of drugs and manufacture of cosmetics and approval
of laboratories for test analysis of drugs is proposed to be perpetual unless otherwise suspended
or cancelled by the Licensing Authority. However, there should be assessment of compliance
with the conditions of licences/approvals at least once in 10 years.
Il. Gap analysis and updation of GMP as prescribed in Schedule M to Drugs & Cosmetics Rules,
1945 to make it at par with WHO GMP guidelines.
All concerned are requested to provide their comments/suggestions/inputs on the above issues to
CDSCO through email: dci@nic.in within two weeks i.e. latest by 215t October, 2016 so that a considered
view can be taken in the matter.
(Dr. G. N. Singh)
Drugs Controller General (India)
— All State/UT Drug Controllers
2. Pharma industry Associations
Copy to:
PPS to AS (F&D), MoHFW/PPS to DGHS/PPS to JS (R), MoHFW