Vaccination policies aim to produce immunity to preventable diseases. Besides individual protection from getting ill, some vaccination policies also aim to provide the community with herd immunity. Vaccination policies have been developed over two centuries mainly to eradicate the identified disease. There are vaccination advisory committees within each country that are usually responsible for providing information to governments, which in turn draft immunization policy regarding the vaccine.

Vaccinations are mandatory in some countries and are made optional in few other countries. When vaccinations are mandatory by the governments usually, the costs are borne by the government. Each year, vaccination prevents between two and three million deaths worldwide, across all age groups, from diphtheria, tetanus, pertussis, and measles.

Eradication of Diseases. A goal for vaccination policies is to eradicate the disease. As a good example, we could see that earlier, the World Health Organization (WHO) coordinated the effort to eradicate smallpox globally through vaccination.

Vaccination Development. Usually vaccine development is a very long and complex process. Sometimes this process even last for 10 to 15 years. Many a time the government and private bodies are together involved in such development of vaccine.

Evolution of the Process. During the 19th century, many human vaccines were developed. Vaccines for smallpox, typhoid, rabies, cholera, plague were developed. However, there were no regulation for vaccine production and marketing.

The US Congress on 1st July 1902 passed an Act to regulate the sale of viruses, serums, toxins and analogous products. This Act was called as Biologics Control Act. This was the first Act to regulate the quality of drugs. The Act further established the government’s right to control the establishment where vaccines were made. The United States Public Services Act of 1944 mandated that the federal government issue licenses for biological products, including vaccines.

The various processes in Vaccine development, manufacturing and marketing all are regulated by strict regulations. The US Public Health Services Act requires that license should be obtained for shipping the vaccine interstate or import/export into the country. WHO recommends that the national regulatory authority should review the plans for development of vaccine and clarify requirements for carrying out clinical trials as well as for marketing approval. The regulation of vaccines can be divided into three stages: 1) development, 2) License and 3) distribution.

Development: The development cycle involves the preclinical and clinical stages. Preclinical testing. Preclinical research and development are carried out in the laboratory using in vitro techniques or when necessary, in vivo techniques in animals. Usually the time frame involved for preclinical testing is 2 to 4 years.

Clinical Trials. The most important stage of the development cycle of vaccine is the clinical trials. During clinical trials the vaccines are tested on humans. Most of the developers find it tough to reach to this stage. The time frame involved is usually between 7 to 10 years.

License stage. The License stage involves the regulatory review. After the success of the clinical trial on human, the developers seeks regulatory backing. The license stage usually takes a very long stage however, during emergencies like covid etc, this cycle term can be shortened.

Distribution. This stage requires a very good infrastructure. This stage also involves lot of financial layout upfront for distribution across the place.

India National Vaccine Policy. India is a major producer and exporter of vaccines. About 45% of the global vaccine supply is provided by Indian manufacturers, primarily from the private sector. Hence, in India there is a robust vaccine policy. This policy with specific relevance to local vaccine needs is required to guide decision making and develop a long-term plan to strengthen the whole vaccine program. The policy further intends to provide a broader guidelines and structured framework for creation of evidence base to justify need for Research and Development, production, quality assessment and distribution of vaccines in India.

The Intellectual Property Rights. The Indian Patent Act was amended in 2005 and the product patents have been allowed in the country, which has significant impact on the cost of health care products in India. The amendment was made with the expectation that there will be more investment in the research and development of the vaccines in the country. This will also encourage technology transfer from multinational companies to develop products and gaining access to technologies and know-how. Indian patent law may have provisions to permit compulsory licensing in special situations like the covid 19 pandemic or in situations, where a technology/intermediate is needed for vaccine development.

K Satish Kumar

K Satish Kumar, is a Keynote Speaker, Author, the Global Head of Legal and Chief Data Protection Officer of Ramco Systems. Among the many awards he has received, the coveted are “Top 50 Legal Leaders 2019” by Legal IP Gorilla in Singapore, “GC PowerListIndia 2018” by London based Legal 500 , “Legal Counsel of the Year -2018” by INBA. He is actively involved in many pro bono activities through Chennai Lawyers. The author can be reached at [email protected]. The views expressed are his personal.

For his other Publications read here.

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