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CDSCO starts special cell to monitor veterinary drugs, vaccines; experts pitch for separate regulatory authority

Arun Sreenivasan, New Delhi
Tuesday, July 10, 2018, 08:00 Hrs  [IST]

There is a felt need to regulate and monitor the drugs being used in farm and domestic animals in the country and the Central Drugs Standard Control Organisation’s (CDSCO) decision to create a dedicated cell at its headquarters to review issues related to veterinary vaccines, drugs and animal safety would resolve the problem to some extent, say experts.

The new unit, the brainchild of Drugs Controller General of India (DCGI) Dr S Eswara Reddy, will also look into issues such as use of antimicrobials in veterinary sector and matters related to aquaculture. The seven-member team, constituted last week, includes a deputy drugs controller to deal with matters related to oxytocin, a peptide hormone misused widely in the dairy and horticulture industry.

“The dedicated unit will be in charge of marketing authorisation, import, registration, licensing and field trials of veterinary vaccines and drugs. We will also look into matters including testing of veterinary biologicals,” Dr SP Shani, deputy drugs controller and a member of the CDSCO’s veterinary cell, told Pharmabiz.

Human and veterinary medicines in India are regulated by the CDSCO. For years, animal health experts and researchers in this medical field have been making a pitch for a separate regulatory agency and an effective pharmacovigilance (PV) programme for the sector, but their demand has fallen on deaf years. Though the regulators were forced to ban various veterinary drugs citing adverse effects on animals and environment, there is no fool-proof system in place to monitor vaccines and drugs. Recently, authorities have banned diclofenac sodium, used in the treatment of bacterial infections, for animal use because of reducing number of vulture population. The manufacture and distribution of oxytocin formulations and its active pharmaceutical ingredient (API) in the private sector was also banned last month citing its misuse by the dairy industry.

“Safety of veterinary medicine is an ignored subject in India. We still fail to understand that the medicines being consumed by animals affect the human population and environment in various ways, as the consumption rate of dairy and other animal-derived products is very high here. The national drug regulator’s decision is indeed welcome, but we need to do a lot more to tackle the core issues in this sector,” Indian Association of Veterinary Microbiologists and Specialists in Infectious Diseases (IAVMI) President MP Yadav noted.

Numerous studies have revealed that adverse drug reaction (ADR) in animals is a major concern. ADRs have a direct impact on animals and indirect impact on humans. The mortality rate of animals in India due to lack of veterinary PV is very high as compared to other developed countries. The concept of veterinary PV is relatively novel in India although countries such as the US, Canada, Europe, Japan, and China have well-established guidelines for it.

“We have enough professionals and experts available, but still need a system in place to monitor the drugs and vaccines used in animals. The DCGI’s new initiative is commendable,” says Dr SM Gadge, a well-known veterinarian in Mumbai. As against the estimated requirement of 67,200 veterinary doctors, there are 67,784 registered practitioners in the country, as per the entries made in the Indian Veterinary Practitioners’ Register maintained by Veterinary Council of India. But animal husbandry is a state subject and veterinary services are provided by respective state government, including deployment of veterinary doctors and para-veterinarians based on requirement. The Central government’s animal husbandry department does not maintain state-wise details of veterinary professionals employed by the states.

According to experts, monitoring veterinary medicines is a challenging and laborious task. The drugs have to be observed for their short- and long-term effects on animals and the impact on the environment. It becomes more important when these animals are further used for producing food. As a result, the need to monitor adverse reactions becomes all the more imperative. Institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centres to assess the safety of medicines, they say. “This is a huge sector and the issues are varied and complex. A small cell at the CDSCO with limited manpower is not adequate to tackle regulatory challenges. We need an exclusive regulatory authority for better veterinary services,” Yadav added.

 

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sharjoon Dec 4, 2019 10:33 PM
I want to take the drug licence to import veterinary medicines for
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