The Ministry of Health and Family Welfare has been amending the New Drugs and Clinical Trial Rules, 2019. The amendment will enable any government or medical institution or private hospital to import the medicines required for the treatment of life-threatening diseases.
The centre had proposed to ease the rules in order to allow the import of any new and untested drug undergoing clinical trials in other countries. The proposed ease in the rules had been for the compassionate use, for those suffering from COVID-19, genetic diseases, or pediatric disorders.
The rules will likely come into effect within two weeks. It will be helpful for COVID-19 patients as it will give them access to the drugs that might be unavailable in India but has been undergoing clinical trials in other countries.
How the new drug will be available?
In case the hospital prescribes a new drug that is unavailable in India, the manufacture can also apply for a special license and manufacture the drug in limited quantities. The manufacturer will be required to get consent from the patient or legal heirs along with the approval from the ethics committee of the hospital. DCGI will then award a license, permitting the manufacture of drugs in limited quantities.
As per the draft amendment, where any medical officer or medical institution can prescribe a new drug for compassionate use. Such a new drug can also be approved to be manufactured in limited quantities subject to the provision of these rules.
What will be the process for approval?
Compassionate use in clinical terms has been defined as the use of a new and unapproved drug for the treatment of a seriously ill patient when no other therapy to cure the disease is available.
As per the officials, the process of the approval has been made simple. The medical institution will have to apply to the Drug Controller General of India (DGCI) and must explain the reason for the ‘compassionate use’ instead of the available therapeutic options.
In the procedure, the description of the patient’s disease, toxicology information and criteria for the selection of the patient will also be required to conclude that the new drug is reasonably safe at the dose and duration that has been proposed for the compassionate use. The application will be required to be addressed within the 30 days.
The draft of the amendment mentions that the central licensing authority, after the scrutiny of the documents and information enclosed with the application, is not satisfied with the requirements, it may reject the application. The reasons will be recorded in writing within a period of 30 from the date of the application.
Need for an amendment in New Drugs and Clinical Trials Rules:
In 2019, the centre had notified the New Drug and Clinical Trials Rules to codify the regulations for trials. However, because of the COVID-19 pandemic, the need for an amendment was felt to expedite the import of new drugs available in other countries.
As per the official from the Central Drugs Standard Control Organisation (CDSCO), the clause has been added to help the patients who are suffering from serious diseases. This will provide early access of medication to the patients suffering from rare diseases, especially children with Orphan diseases or with Spinal muscular atrophy. The clause will also provide a safety net to the doctors prescribing these medicines.
The medicines are expensive and have been manufactured sparingly by drug manufacturers, sometimes the cost goes over Rs. 1 crore per vial.
‘Compassionate use in India’:
Remdesivir has been used in Europe under the ‘Compassionate use’ clause for the treatment of COVID-19. But India had no such provision of compassionate use of drugs.
During COVID-19, the United States had also made some drugs available to countries like Japan under the ‘compassionate use’ clause.
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