**Summary:**
This directive, issued by the Directorate General of Health Services, Office of the Drugs Controller General, Biological Division, addresses the availability of H1N1 (Swine Flu) vaccine and Trivalent Seasonal Influenza vaccine in India. In response to the spread of H1N1 influenza, the communication requests addressees to implement necessary measures to ensure an adequate supply of both vaccines, particularly in affected areas. The directive specifies that the vaccines should be administered under the supervision of Registered Medical Practitioners. Recipients are requested to forward details of actions taken to the issuing office at the earliest. The communication is addressed to the following vaccine manufacturers and distributors: Serum Institute of India Ltd. (Pune), Panacea Biotec Ltd. (Baddi, H.P.), Bharat Biotech International Ltd. (Hyderabad), Novartis Healthcare Pvt. Ltd. (Bhiwandi), Glaxo Smithkline Pharmaceutical Ltd. (Mumbai), Sanofi Pasteur India Pvt. Ltd. (New Delhi), Sanofi Pasteur India Pvt. Ltd. (Mumbai), and Abbott India ltd. (Mumbai).
Key Entities Referenced
Directorate General of Health Services: An Indian government organization under Ministry of Health and Family Welfare.
Drugs Controller General: The head of the Central Drugs Standard Control Organization (CDSCO) in India, responsible for drug regulation.
H1N1 vaccine: A vaccine against the H1N1 influenza virus, also known as swine flu.
Trivalent Seasonal Influenza vaccine: A vaccine that protects against three different influenza viruses.
Serum Institute of India Ltd.: An Indian biotechnology and pharmaceutical company, and the world's largest vaccine manufacturer.
Panacea Biotec Ltd.: An Indian pharmaceutical and biotechnology company.
Bharat Biotech International Ltd.: An Indian biotechnology company focused on vaccine development and manufacturing, located in Telangana State.
Telangana State: A state in southern India.
File No, X11026/24/15-BD
Directorate General of Health Services
O/o Drugs Controller General (1)
(Biological Division)
FDA Bhawan, Kotla Road, New Delhi
a
ce
Bo pe
Sub: Availability of H1N1 vaccine and Trivalent Seasonal Influenza vaccine in the
country.
Sir/Madam,
In light of spread of H1N1 influenza (Swine Flu), you are hereby
requested to take all necessary measures to ensure that there is adequate
supply of H1N1 vaccine and Trivalent Seasonal Influenza vaccine in the
country particularly in the affected areas. The vaccine is to be administered
under the supervision of Registered Medical Practitioners.
Action taken in the matter may please be forwarded to this office at
the earliest.
Drugs Controller General (I)
To,
ran M/s. Serum Institute of India Ltd., 212/2, Hadapsar, Pune — 411 028
2. M/s Panacea Biotec Ltd., (Vaccine Division), Village Malpur, Baddi, Distt. Solan (H.P.)-
173205 ; :
3. M/s Bharat Biotech International Ltd., Genome valley, Shameerpet, Hyderabad, Ranga
Reddy District, Telangana State
4. M/s Novartis Healthcare Pvt. Ltd., Gala 1, BLDG 41, Arihant Complex, Near Kopar
Bus stop, Purna Gaon, Thane-Bhiwandi Road, Bhiwandi.
5S. M/s Glaxo Smithkline Pharmaceutical Ltd., Dr. Annie Besant Road, Worli, Mumbai-
400030
6. M/s Sanofi Pasteur India Pvt. Ltd. , Fourth Floor, Southern Park, DDA Commercial
Centre, Saket, New Dehi-110017,
7. M/s Sanofi Pasteur India Pvt. Ltd. ,54/A Sir Mathuradas Vasanji Road, Andheri (E),
Mumbai-400093 :
8. M/s Abbott India ltd., 3-4 Corporate Park, Sion-Trombay Road, Mumbai-400071