Title : Limits of vaccine quality control in India: Possible solutions
Abstract:
In India, many disease control programs for vaccine-preventable diseases have been running for several decades but such diseases are regularly haunting India. Why? Is it poor vaccine quality, vaccination defect or both? To understand the dilemma we may take the example of the National Animal Disease Control Program of India spending about 0.5 billion US$ every year and this program with different names has been running for the last four decades. Despite so much spending year after year, there is hardly any livestock farm in government or private sector free of Brucellosis and Foot and Mouth Disease (FMD). Brucellosis is endemic and FMD outbreaks occur almost every 3rd year even after regular vaccination. It is either due to vaccination failure or vaccine failure, no one is allowed to speak and investigate truthfully. Most Government farms don’t screen their animals regularly for brucellosis; tuberculosis and Johne’s disease, and even livestock farms in premier veterinary institutions don’t follow the standard control program. What are the main limits? 1. WTO: If you report a communicable disease in your livestock, WTO rules do not permit export, thus no diagnosis; no reporting is binding for most of the regulators and governments unless there is mass mortality and lots of hue and cry in the public it is not reported in Newspapers, and even after so many news of FMD outbreaks you may fail to find the disease in official documents published by the government. 2. No third-party involvement in disease monitoring and reporting, the institution(s) responsible for vaccine quality certification are also responsible for disease diagnosis and disease reporting. If you have passed a vaccine, and an outbreak occurs after vaccination you tend not to report the disease to hide your inefficiency in the first step. 3. No third-party involvement in Vaccine quality control: The premier veterinary institute(s) holding intellectual property rights for most of the vaccines used in India is the only authorized body to assess the vaccines’ quality, the problem arises when you are getting royalty for each dose of vaccines produced how and why you will say that a certain batch is of substandard quality? 4. Pharmaco-political pressure: Most of the pharmaceuticals producing vaccines in India (and maybe elsewhere also) have big shares of powerful politicians, politically strong industrialists or are in the government sector, then who can dare to say truthfully about the vaccine quality, especially when the whole vaccine quality control, disease investigation and disease reporting is done by the same department. The pressure can be felt by the fact that the sampling of products of certain pharmaceuticals is either not collected or collected rarely by drug inspectors working under the Central Drugs Standard Control Organisation (CDSCO). Even after the declaration of repeated substandard quality of medicines and vaccines produced by the specific pharmaceutical(s) by CDSCO, it is rare to hear any harsh action against them. 5. Insufficient vaccine testing facilities: In India there is hardly any pharmaceutical/ vaccine producer(s) following QA and QC standards mentioned in Indian pharmacopoeia, even many of them don’t have the required facility, but they produce thousands of vaccine batches every year. The CDSCO India has only one authorized centre for animal vaccine quality assessment which has to certify all those batches of vaccines every year, interestingly without having any animal bio-safety level three (ABSL-3) facilities, without procuring specific pathogen-free (SPF) animals and SPF eggs/ chicks for vaccine safety and efficacy testing of veterinary use vaccines. The solution(s): Education of livestock farmers to understand their rights to have good quality vaccines, transparency in the vaccine quality control, disease investigation, disease monitoring and reporting can only improve the situation. However, the caucus getting fruits of the persistence of diseases in India may never allow it to happen, it is a very hard nut to crack, yes whosoever will try to crack it must be ready to make sacrifice(s) and be punished.
