As the deadly coronavirus pandemic continues to ravage the country, scientists and doctors are struggling to generate drugs, vaccines, and other medical strategies to tackle the disease. Various new treatments and experimental drugs are being developed by the medical associations using trial and error methods, hoping to find some effective therapy to combat the virus. Recently, the Ministry of Health and Family Welfare has circulated a draft providing information about the "compassionate usage" of unauthorised antiviral drugs that stands in the clinical trial's phase III worldwide. This has been decided by the Ministry to help the critical COVID-19 positive patients, who can access the new drugs.
The amendment rules for drafting experimental drugs and clinical trials have set forth the manufacturing and import of the unregistered drugs, only if the hospitals or healthcare centre provides a valid prescription of that particular drug.
The official periodical notice was published on June 5, which carried all the draft regulations. It stated that an experimental drug could be imported by a medical centre or hospital for "compassionate use for the treatment of patients suffering from a life-threatening disease, or disease-causing permanent disability, or disease requiring therapy for unmet medical need". However, this will still not be considered authorised in the nation, as presently, it stands at stage III clinical trial (experimentation on the human body) countrywide or across the country. This can be availed by applying to the Central Drug Regulator.
However, the rules and regulations issued should be strictly followed. According to the guidelines, if a medical institution is prescribing a new drug for a similar usage, they may be permitted to manufacture it -- but only in restricted quantities.
While manufacturing an unapproved drug, the manufacturer has to submit an application to the Ethics Committee of the medical centre or hospital for acquiring special guidance for manufacturing an experimental drug, but he can only do so after seeking written permission from the patient, who has been prescribed the drug, or his close relatives.
After the manufacturer receives proper directions from the Ethics Committee, he has to receive the consent of the Central Licensing Authority drafting an application to manufacture the drug for "empathetic use," according to the norms.
"The manufacturer to whom the permission is granted shall make use of the new drug only for the purposes specified in the permission, and no part of it shall be sold in the market or supplied to any other person, agency, institution or place," it read.
The amended rules will be finalised by the Central Government of India following which it will be printed in the official gazette of India. However, this will be possible only after the people submit their objections or proposals to the government within 15 days, as the draft rules will be applicable until then.
The latest rules have been placed under Section 96, which includes application filing, permitting the license to the manufacturer, the terms and cancellations of the licenses and others.
The licence will be valid for one year for manufacturing and importing purposes starting from the day of its issuance.
If the licence holder, manufacturer or importer does not follow the norms, the Central Licence Authority may give him a chance to prove himself but can suspend or terminate the licence for a definite period, depending on the situation. He/She can be eliminated either permanently or because of the particular provisions he/she violated.
According to the draft norms, the quantity of the drugs should not be more than one hundred dosages per patient on an average. But in some special cases, on the direction of the Ethics Committee or any doctor prescription, larger quantities will be permitted to be manufactured.
The application should also contain the details of the drug usage, dosage and the time scale of the treatment, including the patient details and his/her illness, and even the reasoning behind its usage.
The details of the manufacturing units, clinical process, lab tests etc. should also be included to analyse the effects of the drug properly.
Recently, a drug called Remdesivir is proving effective on the patients has been approved for "restricted emergency use". Scientists are still working on to come up with effective and experimental antiviral drugs until the vaccine gets introduced worldwide.