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Indian Pediatr 2009;46: 1025-1026


Vijay Yewale,
Vipin Vashishtha

IAP Committee on Immunization 2009-10.
Email: vnyewale@gmail.com 

A vaccine must be licensed first by the appropriate authority for the use in the country. The vaccines/drugs licensing authority in India, i.e. National Regulatory Authority (NRA) is Drugs Controller General of India (DCGI) which is approved by WHO also. For licensing of a new vaccine, the vaccine manufacturer should conduct the phase I, II, and III trials and must submit their results to NRA for its approval.

There are both central and state licensing authorities. Good clinical practice (GCP) and ethical guidelines (by ICMR) for approval exist. Licensing of products in India is by the Central Licensing Approval Authority (CLAA). The Drug Technology Advisory Board (DATB) approves introduction of vaccines into the immunization services, while all vaccine approval and clinical trials is by the CLAA. The state licensing authority inspects and grants licensing for retail.

Imported products are considered on a case-by-case basis; if trials meet the requirements of the NRA, there is no insistence on clinical trials in the country for registration. The advisory committees that review the information follow published guidelines, directed by a responsible person. External clinical experts may be asked for advice on a case-by-case basis.

After licensing, the vaccine manufacturer should undertake a large post-marketing surveillance (Phase IV) to further ensure the safety of their products. Any complaint regarding the safety, efficacy, etc of the licensed vaccine should be directed to NRA. Once the vaccine is licensed in the country, it can be used both by the private as well as the public sector. All the vaccines recommended by IAP-COI are approved by WHO.

The combining of multiple related or unrelated antigens into a single vaccine is not a new concept. Several combination vaccines have been in use including the trivalent influenza accines, diphtheria, pertussis and tetanus toxoids (DTwP, DTaP, DT, Td, Tdap), the polio vaccines, MMR and meningococcal vaccines. Additionally, several other multivalent vaccines have been recently introduced including the pneumococcal, rotavirus and HPV vaccines.

The advantages of combination vaccines are multiple and include fewer injections, reduced burden on the cold chain, reduced requirement of syringes and needles, and easier record keeping. However, the concerns and fears of stability of the new combination products and immune interference between the various antigens leading to suboptimal immunogenicity have been raised by many but so far do not have much basis and for all practical purposes each individual constituent does have equally protective efficacy as when given separately. Furthermore, the combination vaccines are also treated like any other new vaccine and they also need to undergo the same process of clinical trials and licensing as applicable to a new vaccine.


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