**Executive Summary:**
This document addresses a Lok Sabha Starred Question regarding the quality and testing of anti-rabies vaccines procured for distribution through public hospitals in India. It outlines the mandatory quality requirements for manufacturers and importers of anti-rabies vaccines, emphasizing compliance with the Drugs and Cosmetics Act, 1940, and associated rules. It confirms that the Kerala Medical Services Corporation (KMSCL) has procured and distributed only those rabies vaccines and Equine AntiRabies Immunoglobulins with Batch Release Certificates from the Central Drugs Laboratory (CDL) since 2016-17.
**Key Points / Main Content:**
* **Quality and Manufacturing Requirements:**
* Manufacturers/importers of anti-rabies vaccines must comply with quality, safety, and efficacy standards as per the Drugs and Cosmetics Act, 1940 and Rules.
* Manufacturing/import licenses are mandatory under the Drugs and Cosmetics Act, 1940 and Rules.
* **Indian Pharmacopoeia (IP) Compliance:**
* Anti-rabies vaccines must adhere to the standards specified in the current edition of the Indian Pharmacopoeia.
* **Quality Control and Batch Release:**
* Each batch must undergo complete in-house quality control testing as per validated procedures and IP standards.
* Each batch/lot requires release by the Central Drugs Laboratory (CDL), Kasauli, before sale and distribution.
* **Storage and Handling:**
* Proper cold chain logistics (2°C to 8°C) must be maintained during storage and transportation.
* Vaccines must have a valid remaining shelf life at the time of supply and proper packaging.
* **Regulations and Enforcement:**
* Vaccines are classified as new drugs under the New Drugs and Clinical Trial Rules, 2019.
* Manufacturers must comply with mandatory quality tests and license conditions under Drug Rules, 1945.
* The Central License Approving Authority (CLAA) and State Licensing Authorities can take action against violations.
* **Kerala Medical Services Corporation (KMSCL):**
* Since the tender year 2016-17, KMSCL has only procured and distributed rabies vaccines and Equine AntiRabies Immunoglobulins with Batch Release Certificates from CDL, Kasauli.
**Impact Analysis:**
**Manufacturers/Importers of Anti-Rabies Vaccines:**
* *Impact:* Must adhere to stringent quality control measures, obtain necessary licenses, and ensure batch release from CDL before distribution.
* *Action Required:* Comply with all requirements of the Drugs and Cosmetics Act, Indian Pharmacopoeia standards, and CDL batch release protocols.
**Central Drugs Laboratory (CDL), Kasauli:**
* *Impact:* Responsible for testing and releasing batches of anti-rabies vaccines before they can be distributed.
* *Action Required:* Maintain efficient testing and batch release processes to ensure timely availability of safe and effective vaccines.
**State Procurement Corporations (e.g., KMSCL):**
* *Impact:* Must procure only anti-rabies vaccines with valid Batch Release Certificates from CDL.
* *Action Required:* Ensure that all procured vaccines meet the specified quality standards and have the necessary certifications.
**Public Hospitals and Healthcare Providers:**
* *Impact:* Can be assured of the quality and safety of anti-rabies vaccines distributed through public channels.
* *Action Required:* Utilize only vaccines that have been properly tested and certified.
**Patients:**
* *Impact:* Increased assurance of receiving safe and effective anti-rabies vaccines.
* *Action Required:* No direct action required, but should be aware of the quality control measures in place.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: An act in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Indian Pharmacopoeia: The official book of standards for drugs manufactured and/or marketed in India.
Central Drugs Laboratory CDL: A central drug testing laboratory in India responsible for testing and releasing batches of vaccines. Located in Kasauli, Himachal Pradesh.
Kasauli, Himachal Pradesh: Location of the Central Drugs Laboratory (CDL) in the state of Himachal Pradesh, India.
New drugs and Clinical Trial Rules, 2019: Rules pertaining to new drugs and clinical trials in India.
Drug Rules, 1945: Rules pertaining to drugs in India.
Kerala Medical Services Corporation KMSCL: The medical service corporation of Kerala responsible for procuring and distributing drugs.
Anti Rabies vaccines: Vaccines used for the prevention and treatment of rabies.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
STARREDQUESTION NO. 186
TO BE ANSWERED ON1STAUGUST,2025.
TESTING OF ANTI-RABIES VACCINES
*186. ADV. DEAN KURIAKOSE:
Will the Minister of HEALTHANDFAMILYWELFAREbe pleased to state:
(a) the details of mandatory requirements prescribed for ensuring the quality of Anti-
Rabies vaccines procured by the State procurement corporations for distribution through
public hospitals;
(b) whether it is mandated that the manufacturers supplying anti-rabies vaccine are
required to have quality testing reports from Central Drug Lab for distribution through
public hospitals and if so, the details thereof;
(c) the details of the patient safety issues of administering the anti-rabies vaccines that has
not undergone mandatory quality tests;
(d) whether the manufacturers supplying anti-rabies vaccine to Kerala Medical Services
Corporation has done the mandatory tests from Central Drug Lab during the last five years
and the current year; and
(e) if so, the details thereof, year-wise?
ANSWER
THE MINISTER OFHEALTH AND FAMILYWELFARE
(SHRIJAGATPRAKASH NADDA)
(a)to(e): AStatementislaid on the Tableof the House.STATEMENTREFERRED TOIN REPLYTO LOK SABHASTARREDQUESTION
NO.186 FOR1STAUGUST, 2025
******
(a)& (b): For manufacturing/import of new drugs including vaccines, the
manufacturers/importers are required to comply with the standards of quality, safety and
efficacy asprescribed inDrugs andCosmetics Act, 1940andRulesthereunder.
The following mandatory quality requirements are prescribed toensure the quality of
anti-rabiesvaccinesbeing manufacturedinthe country:
(i) Manufacturing Licence/import license issued under the Drugs and Cosmetics Act,
1940andRulesthereunder.
(ii) Compliance with Indian Pharmacopoeia (IP) - The anti-rabies vaccine must comply
with the standards specified inthe current editionof the IndianPharmacopoeia.
(iii) In-House Quality Control Testing - Each batch must undergo complete in-house
quality control testing at the manufacturer's facility as per validated procedures and IP
standards.
(iv) Batch Release from Central Drugs Laboratory (CDL) - Each batch/lot of vaccines
manufactured/imported in the country is required to be released by Central Drugs Laboratory
(CDL), Kasauli, HimachalPradesh,before release of vaccinesfor sale anddistribution.
(v) Cold Chain Maintenance- Proper cold chain logistics 2°C to 8°C must be maintained
throughout storage andtransportation topreserve vaccinepotency.
(vi) Shelf Life andPackaging- Vaccinesmust have a validremaining shelf life at the time
of supply andshould be packagedtoensure protection during transit andstorage.
(c): As per Rule 2(w) of New drugs and Clinical Trial Rules, 2019, vaccines are always
be deemed to be new drugs. All manufacturers of vaccines have to comply with the
conditions of mandatory quality tests apart from other conditions of license as prescribed
under Rules 78 & 78A of Drug Rules, 1945 and both the Central License Approving
Authority (CLAA) and State Licensing Authorities are empowered to take stringent action
against violationof provisions of the Act andRules.
(d) & (e): As informed by Kerala Medical Services Corporation (KMSCL), all Rabies
Vaccines and Equine Anti-Rabies Immunoglobulins procured and distributed by them from
the tender year 2016-17 onwards have obtained Batch Release Certificates from Central
Drugs Laboratory (CDL), Kasauli, as mandated in the tender terms and conditions. KMSCL
has not procured or distributed any batch of Rabies vaccine or Equine Anti-rabies
Immunoglobulinwithout a batch release certificatefrom CDL.
********