Vultures in a nest in Orchha, Madhya Pradesh. Photo: ©Yann Forget/Wikimedia Commons, CC BY-SA 4.0
- The Central Drugs Standard Control Organisation has said aceclofenac, nimesulide and ketoprofen cannot be banned for veterinary use even though they are toxic for vultures without the concurrence of the Department of Animal Husbandry and Diarying.
- Interestingly, the animal husbandry department says it has no information on whether “it has any policy on protection and conservation of vultures”.
- The strategy laid out in the ‘Action Plan for Vulture Conservation (2020-25)’ says that India’s drug regulator has to institute a system where any drug that is demonstrably found to be toxic to vultures must be automatically removed from the market.
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has passed the buck on banning three drugs that are used to treat livestock but are toxic for vultures – a protected species – to the Department of Animal Husbandry and Diarying, expressing its inability to take the decision without the latter’s concurrence.
The CDSCO’s statement runs contrary to the strategy laid out in the ‘Action Plan for Vulture Conservation (2020-25)’, which says that India’s drug regulator has to institute a system where any drug that is demonstrably found to be toxic to vultures must be automatically removed from the market.
The drug regulator made the submission in an affidavit filed in the Delhi high court in an ongoing case on vulture protection. The case was heard on Tuesday, December 13, 2022, when the court asked the regulator to file a status report on the steps it has taken to protect India’s vultures, according to the petitioner in the case Gaurav Bansal, a Supreme Court lawyer.
The CDSCO said that it cannot ban three drugs – aceclofenac, nimesulide and ketoprofen – for veterinary use without the concurrence of the animal husbandry department, which falls under the Union Ministry of Fisheries, Animal Husbandry and Dairying.
These three are among many drugs classified as toxic non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain, fever and other inflammatory conditions in livestock like cattle. When vultures consume the carcasses of animals treated with these medicines, they also consume the toxic effects of the drugs, leading to kidney failure.
Three species of vultures – including those that have witnessed drastic population declines – are listed in Schedule I of the Wildlife Protection Act, 1972, which affords them the highest level of protection in Indian law.
The decline in vulture populations was highlighted in the mid-80s, and in 2004 the cause of the crash was established as diclofenac, a veterinary NSAID. Bansal’s affidavit, quoting a statement from the MoEFCC, said the vulture population has declined from 40 million to 19,000 in the last three decades.
Though the Drug Controller General of India (DCGI) – the CDSCO’s head – banned the veterinary use of diclofenac in 2006, its illegal use continues. In 2015, the DCGI also restricted the vial size of the human formulation of diclofenac to prevent its misuse. Aceclofenac, one of the three drugs that the petition in the Delhi high court seeks to be banned, gets metabolised into diclofenac.
The Wire Science had earlier reported that the CDSCO was dragging its feet in banning aceclofenac, nimesulide and ketoprofen for veterinary use despite the Wildlife Institute of India (WII) and the Indian Veterinary Research Institute (IVRI) – both set up by the Union government – writing to it on several occasions to prohibit their use.
Interestingly, the animal husbandry department, to which the CDSCO has deferred the decision now, says it has no information on whether “it has any policy on protection and conservation of vultures”.
Bansal had filed a Right to Information (RTI) application with the animal husbandry department on July 8, 2022, asking if it had a policy for vulture conservation and if there was any official file to that effect. The department transferred his application to the Animal Welfare Board of India (AWBI), which works under its aegis. AWBI replied, “The information sought is not available with the Board.”
Now, the CDSCO has told the Delhi high court that it had written to the animal husbandry department at least four times in the past seeking its opinion on banning the drugs. The drug regulator said:
“It is humbly submitted that for prohibiting/banning of Veterinary Drugs by Ministry of Health and Family Welfare [under which CDSCO functions], the Expert opinion from the Department of Animal Husbandry and Dairying is required. Decision regarding approval of new drugs for veterinary use is done in accordance with review/comments by Department of Animal Husbandry and Dairying.”
The regulator also said that as per the Drugs and Cosmetics Act 1940, its approval for new drugs for animal use has to rely on the assessment of clinical data done in “coordination” with the animal husbandry department.
The CDSCO furnished copies of four letters written in 2019, 2020, 2021 and 2022 to the court.
In the letter written on July 8, 2019, the CDSCO told the department that it had received a letter from Haryana’s drug controller advocating for the prohibition of aceclofenac for veterinary use. On December 22, 2020, it sent a reminder to the Department, adding that Goa’s drug controller had also made a similar pitch not just for aceclofenac but also ketoprofen. In 2021 and 2022 also, it sent similar letters to the department.
In the last letter, written on June 23, 2022, the CDSCO wrote:
“In view of above [reminder of earlier letters], you are once again requested to kindly examine the matter and convey your expert opinion at the earliest, so as to take further necessary action for banning of Ketoprofen & Aceclofenac for treatment of livestock animals to conserve vultures.”
The CDSCO told the Delhi high court that it did not get a response to any of these letters. Therefore, it could not take any action on the prohibition or ban of the three drugs for veterinary use and is waiting to hear from the animal husbandry department.
What does the conservation plan say?
While the CDSCO is relying on the animal husbandry department to ban these three drugs for use in animals, the ‘Action Plan for Vulture Conservation (2020-25)’, prepared by the Union Ministry of Environment, Forest and Climate Change (MoEFCC), envisages no role for the latter in drug regulation.
Though the plan is to be implemented by MoEFCC, there is “very little” that the ministry can do on its own “as the cause of crash in vulture populations is the veterinary use of NSAIDs”.
As far as drug regulation is concerned, the plan says:
“[While] the licensing and the distribution of the drugs is the responsibility of the Drug Controller General of India [CDSCO’s head] of the MoH&FW, [the] dispensing and administration is the responsibility of the Animal Husbandry Commissioner of the Ministry of Animal Husbandry, Dairying and Fisheries.”
Indeed, the plan gives four specific responsibilities to the department of animal husbandry but all of them are related to implementing the decisions that are taken by the National Committee for Implementation of the Action Plan, and ensuring that there is no illegal use in treating animals.
The DCGI – the head of the CDSCO – is also a member of the national committee formed for the implementation of the vulture conservation plan.
The plan also says:
“If a drug is found to be toxic by a scientific study and it is published in [a] high impact factor international journal, it should be automatically removed from the veterinary market once the paper is reviewed by the technical committee of DCGI.”
Now, according to an affidavit submitted by the non-profit organisation Bombay Natural History Society in the ongoing Delhi high court case, studies have been published since 2010 showing the toxic effects of aceclofenac, nimesulide and ketoprofen. The details of the affidavit were earlier reported by The Wire Science.
The plan, which was published in 2020, also explicitly mentions that the DCGI must institute a system to ensure that drugs that are toxic to vultures like “aceclofenac and ketoprofen are banned for veterinary use.”
The WII, which functions under the MoEFCC, is of the view that banning these three drugs will not impact the treatment regimen for cattle and livestock, listing alternative medicines in a letter addressed to the ministry on July 7, 2022.
The IVRI, which reports to the Indian Council of Agriculture Research, also recommended the same alternatives in its July 21, 2022 letter to the environment ministry, as reported earlier.
Now, the CDSCO has to file its reply within four weeks.