Market mapping and landscape analysis of human rabies biologicals in India

Background: Rabies vaccines and immunoglobulins are lifesaving in humans following animal exposures. These biologicals should continuously be available throughout the year to prevent and eliminate human rabies by 2030. Objectives: The present study aimed at assessing availability of different kinds of human rabies biologicals in the country and undertaking market mapping and landscape analysis of human rabies biologicals in India. Methods: The study comprising both quantitative and qualitative approach was conducted from May to November 2017 as a part of the Indian multicentric rabies survey by Association for Prevention and Control of Rabies in India. All stakeholders (agencies/personnel) associated with rabies biologicals were the study units/participants. Required data were generated through brainstorming sessions with key stakeholders; reviewing of databases/existing literature; conducting in-depth surveys; interviewing; focused group discussions, etc. Results: Two types of cell culture rabies vaccines are available in the country manufactured by different pharmaceutical companies; most of the vaccines are indigenously produced and the market size of the rabies vaccines is about INR 125 crores with highest sales in the northern region followed by South. Likewise, there are 2 types of immunoglobulin available, i.e., equine rabies immunoglobulins (RIGs), which are indigenously produced and human RIGs, which are imported. The market value of RIGs is about INR 83 crores. A novel rabies monoclonal antibody is also been marketed in the country from November 2017. Conclusions: There are many lacunas in the market availability of rabies biologicals in different parts of the country; therefore, a significant expansion/shift in focus must be considered, through rigorous strategic planning process.

Facilities and services of postexposure prophylaxis in anti-rabies clinics: A national assessment in India

Background: The rabies postexposure prophylaxis (PEP) is provided through anti-rabies clinics in the country. It was considered important to assess their facilities under a nationwide multi-centric survey. Objectives: The objective of this study is to assess the facilities available for PEP at the anti-rabies clinics and to ascertain the PEP provided at the anti-rabies clinics. Methods: The cross-sectional assessment was made from May 2017 to January 2018 in selected seven states of India. Thirty-five anti-rabies clinics from both Government and private; urban and rural areas from the states were assessed by an expert team using a pretested checklist for facilities and services available for PEP. Results: On an average, 10 new animal bite cases were attended at each anti-rabies clinic per day. The cold chain facilities for rabies biologicals were satisfactory. The facilities for wound washing (54.3%) and the use of antiseptics to animal bite wounds were not adequate. Rabies vaccines were administered by intramuscular in 54.3% and by intradermal route in 45.7% of the cases. The vaccine stock-outs were reported only in the government sector (18.5%). The type of rabies immunoglobulin (RIG) used was equine (63.2%) and human (36.8%); given free of cost in 40% of Anti rabies clinics. The local wound infiltration of RIG was in practice at 58.6% of anti-rabies clinics. The stock-out of RIG was more in private (50%) hospitals than in Government (40.7%) hospitals. Conclusion: The facilities available for PEP at the anti-rabies clinics were inadequate and have to be improved across the country.

Appraisal of surveillance of human rabies and animal bites in seven states of India

Background: The key to understanding the burden of animal bites and rabies lies in accurate and timely data with the help of proper surveillance system across the country. Such a surveillance system needs to be evaluated also for a programmatic purpose. Objectives: The present study was conducted to appraise the surveillance system of human rabies and animal bites in seven states of India and also to describe the characteristics of human rabies cases in the states. Methods: The record-based study was conducted from July to December 2017. The survey team collected information about the surveillance status of human rabies from the infectious diseases hospitals and animal bites from integrated disease surveillance programme (IDSP) offices of the respective states for 2012�16. At the national level, also number of animal exposures and the human rabies cases were collected from the Central Bureau of Health Intelligence and IDSP and compared for concordance. Results: There was a gross underreporting of human rabies from the states to Government of India, and there was no concordance in the reports of animal bites between the IDSP offices of the states and NCDC, New Delhi, India. There was a gradual decline in the reported cases of human rabies from the states during the 5-year period of 2012�16, attributable to improvement in the overall rabies postexposure prophylaxis services. The documentation of information of the human rabies cases was poor in the infectious disease hospitals. Conclusion: The surveillance system on human rabies and animal bites in India has to be improved under the national rabies control program to eliminate rabies by the year 2030.

Background paper for developing a policy for the use of rabies biologicals and vaccination of humans in India

National Rabies Control Programme, India, is in operation since 2012�13 without much impact due to poor funding and no set policy for the rabies prevention and control. An effort was made to develop a draft policy paper which can help the Government of India to develop a national rabies vaccination policy for humans and for achieving the goal of zero dog-mediated human rabies deaths by the year 2030. A technical stakeholders meeting was held under the chairmanship of the Drug Controller General of India at New Delhi in December 2017 to discuss the problems and solutions for providing essential rabies postexposure prophylaxis (PEP). The following problems and dilemmas were identified: frequent shortages of life-saving rabies vaccines and rabies immunoglobulin for PEP; as rabies vaccines are mostly procured by the state governments that often face resource crunch and hurdles in logistics within the states; production levels of rabies biologicals in the public sector are low; and the export of rabies biologicals from the private sector needs to be critically evaluated in the context of frequent stock-outs in the domestic market and also the national vaccine security.