It was in 1940, the Parliament had promulgated the Drugs and Cosmetics Act that primarily regulated the import ,manufacture ,distribute and sale of drugs and cosmetics throughout the whole country. The pace at which the healthcare industry has been booming in the country ,marking it to the Asia’s fourth largest medical technology sector in India. The loopholes and the barriers that were prevalent in the pre independence legislation escaped in ensuring guidelines & regulatory approval processes and for quality benchmark are on par with global standards.
In July 2022, the Ministry of Health and Family Welfare proposed a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 with an intent to evaluate , replace and modernize and remodel the waning and outmoded the Drugs and Cosmetics Act, 1940 where the ministry has been persistently reviewing and streamlining the rules to further adopt the new technology , accommodate the changes , consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, safety, efficacy, performance; and clinical trial of new drugs and clinical investigation of medical devices. The Ministry of Health and Family Welfare constituted an eight member committee headed by Drug Controller General of India, Mr. V.G. Somani for drafting the bill.
REASON FOR THE NEED OF A COMPREHENSIVE BILL
The National Institute for Transforming India (NITI) Aayog adduced three reasons predominantly for the purpose of signifying a new and separate law for medical devices: The Drugs and Cosmetics Act of 1940 is outmoded; hence the act cannot govern medical devices in the robust and wholesome manner ;Deficiency or the paucity of human expertise in the Central Drugs Standard Control Organization (CDSCO) to check the safety and potency of medical devices; the professionals in the CDCSO have chemical-based knowledge that only applies to pharmaceuticals and lack of knowledge regarding the complex electronic technology that comes with some medical devices; Due to a lack of resources to check the quality of devices, they propounded only regulating Category A devices such as pacemakers that are intrusive and placed inside the human body. It was indeed the right time to amend the law and have the regulations for clinical trials and investigations for drugs and medical devices since India is called as indigenous medical device industry valued at Rupees Two Hundred Fifty Crore and is projected to grow higher.
Indian generics firm Maiden Pharmaceuticals has been inculpated in the demise of sixty six children in The Gambia, West Africa. On 5 October, the World Health Organization (WHO) alarmed to have the focal point on four substandard cough syrups: Promethazine oral solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all manufactured by Maiden, which is based in the north Indian state of Haryana. These products are ‘linked with acute kidney injuries and sixty six deaths among children’ in The Gambia, the report disclosed. ‘WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients,’ director general Tedros Ghebreyesus stated. ‘All this is happening because neither the regulatory authorities nor the pharmaceutical companies go by the rulebook,’ says Chinu Srinivasan, co-convenor of the non-profit All India Drug Action Network, which focuses on people-oriented health and drug policies. ‘It’s a fault of both the state and central regulatory authorities that the culprits always get away with just a slap on the wrist after getting caught. What we badly need is transparency, predictability of the system and integrity.’ According to World Health Organization (WHO) statistics, renal failure was the cause for the death of sixty six children in the Gambia who had allegedly taken cough syrups produced in India. The WHO has given a signal over four cough syrups manufactured by India’s Maiden Pharmaceuticals, as per several media reports. The Indian government has asked the WHO to furnish evidence of direct causal links between the contaminated syrups and deaths. According to Indian officials, out of twenty three samples tested, as per WHO, four were found to contain diethylene glycol and ethylene glycol. ‘While it is hard to establish a firm causal link, and investigations are still ongoing, we know that these contaminants (diethylene glycol and ethylene glycol) are toxic to humans when consumed and can prove fatal,’ WHO told Chemistry World in their report. However “None of four cough syrups linked to death of sixty six children in Gambia available for sale in India, is being stated by the distributors. With these reports the barriers and the drawbacks of the existing laws have come in to the picture.
US Pharma major Johnson & Johnson (J&J) Private Limited had consented at Delhi High Court to pay compensation to patients affected by its faulty acetabular surface replacement (ASR) hip implants.
The Articular Surface Replacement device is a metal on metal device with cobalt and chromium as predominant components. They have been manufactured and distributed by DePuy for a prolonged time. They were produced on metal on metal contemplating that the implant could be long lasting and help in escalating the ability to move freely. But painfully , for the company the metal on metal configuration has rather generated surprisingly high disappointment rates explicitly in view of metal-on-metal grinding that discharges a very small amount of metal into encompassing tissue.
DePuy hip implants may cause and produce maximal side effects or reactions such as: Metallosis, a metal fragment and particle discharge causing morbidity.
Necrosis, bone and other tissue demise from metallosis poison. Osteolysis, a bone disintegration because of the metallosis toxicity. Systemic metallosis an entire body irritation from metal particles. Pseudotumors an evolution of tumour like particles encompassing joints thereby harming them. Bone Fracture a debilitating and breakage of bones encompassing the implant. Because of these faulty implants, the skin, tissues and bones near the implants gets defaced and affected severely. Revision Surgery or Reconstructive Surgery is the only answer to this and the Patients who received these metal on metal implant devices may need replacement surgery or reconstructive surgery to repair tissue damage and joint failure due to the faulty devices. These revision and reconstructive surgeries are most of the time invasive to the body and more agonizing than the primary hip implant surgery. Patients are required to experience longer and huge restoration periods and are presented to extra surgical and recuperation dangers which is inclusive of the contamination, aggravation, agony, and idleness in the body parts. Some patients go through different medical procedures such as multiple surgeries to fix the repair or harm brought about by the DePuy faulty implants. There are no tools accessible to Indian regulators under the framework and the structure to hold makers of sub-standard medical device manufacturers accountable .At most, the Health Ministry can prohibit the manufacture and sale of certain medical devices under Section 26A or cancel a license to avert further harm.
As per “Section 26A in the Drugs and Cosmetics Act, 1940 , Powers of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest. Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, [regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.”
In the J&J case, the manufacturer sold devices to doctors and hospitals instead of patients directly, so it did not have a list of patients who had these devices implanted. Doctors and hospitals lack incentives to share the patient list and even if they want to, legal liability for surgically faulty devices in the patient’s body would stop them from doing so. These are few of the case studies that show the need of a comprehensive legislation.
KEY HIGLIGHTS THAT HAS BEEN INCORPORATED IN THE BILL
The bill has been acknowledged by many industry as the bill is addressing the barriers in the booming of the health care industry.
The important definitions pioneered under the bill in Chapter 1are given as under:
Clinical Trial is defined as any systematic study of new drug or investigational new drug or bioavailability or bioequivalence study of any new drug in human participants to generate data for discovering or verifying its clinical, pharmacological, including pharmacodynamic and pharmacokinetic, or adverse effects with the objective of determining safety, efficacy or tolerance of the drug.
Over-the-counter Drugs construed as drugs that can be sold by way of retail to a consumer without prescription from a registered medical practitioner as per the conditions and in such manner as may be prescribed.
Investigational New Drug elucidated as new chemical or biological entity or substance which is under investigation in a clinical trial regarding its safety, tolerance and efficacy.
Proprietary Medicine means a drug which is a remedy or prescription presented in a form ready for internal or external administration on human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being in force or any other Pharmacopoeia authorized in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board.
In section 3 (o)defined “drug” includes-(a) medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects;(b) substances, other than food, intended to affect structure or any function of the human body or intended to be used for the destruction of vermin, insects or microbes which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification. (c) substances intended for use as components of a drug including empty gelatin capsules; and(d) any active pharmaceutical ingredient.
Full report can be read on the website.
In section 3(zk)“over the counter drugs” elucidated as drugs that can be sold by way of retail to a consumer without prescription from a registered medical practitioner as per the conditions and in such manner as may be prescribed
In section 3 (zd) “medical device” includes- (a) all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body
or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the
specific purposes of,- (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;(iv) supporting or sustaining life;(v) disinfection of medical devices;
(vi) control of conception; (b) in-vitro diagnostic device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes by means of examination of specimens derived from the human bodies or animals.
Medical devices to be treated distinctly from Drugs: At present, all medical devices are incorporated as ‘Drug’ and governed under Drugs & Cosmetics Act and Medical Devices Rules 2020. The draft Bill now aims to repeal the current laws and propounds a new elucidation for medical devices placing them outside the purview of ‘Drugs’. Also, Chapter II of the draft Bill has a recommendation for constitution of a Medical Devices Technical Advisory Board (MDTAB), distinct from Drug Technical Advisory Board (DTAB), inclusive of specialists from various associations to recommend the Central Government in technical matters.
Under the new draft Bill, provisions to name or build medical device testing facilities for the objective of evaluating and testing medical devices for regulators and business have also been encompassed. Constitution of the Drugs, Medical Devices and Cosmetics Consultative Committee: To advise the Central Government, the State Governments, the Drugs Technical Advisory Board and the Medical Devices Technical Advisory Board on any matter and to secure conformity in the country in the administration of this Act and the rules made thereunder. The Drugs Controller General, India (DCGI) shall be the Chairperson of the said Committee. Chapter III deals with standards being laid down for import of drugs and cosmetics. Chapter IV allocates with manufacture, sale and distribution of drugs and cosmetics and clinical trial of drugs. Chapter V of the draft Bill has a separate chapter for Ayurvedic, Unani, and Siddha drugs and cosmetics that are exclusively covered by the D & C Act. In addition, such Chapter aims to regulate Sowa Rigpa and homoeopathy for the first-time including standardising its import, manufacture, sale, distribution and clinical trial of such products. Whereas Chapter VI deals with standardising import, manufacture, sale and distribution and clinical investigation of medical devices.
The rampant growth of E PHARMACIES makes it mandatory to have a provision in law to regulate. The Bill has for the first time expounded a regulatory mechanism for online sale of drugs and cosmetics, making it mandatory for every person who stocks, exhibits, sells or distributes any drugs through online mode to get a license or permission from the Authority, though there are no exact guidelines on the procedures for acquiring license, nonetheless Section 83(2)(l) mentions that Central government would makes rules prescribing the manner for regulation and restriction for online mode of sale of medicines.
The punishments are made more strict and stringent, the bill augments the period of imprisonment between one to ten years that may broaden to life imprisonment and amount of fine up to Rupees Fifteen lakhs for not complying with of provisions of the bill. Furthermore, the Bill puts in motion penalty provisions for clinical trial and clinical investigation without permission, and for dereliction to provide compensation for injury or death related to clinical trial.
CONCLUSION
The current legislation replacing the outdated 1940 Act is indeed a right step to revamp and regulate the healthcare industry as a whole which adapts and accommodate the required changes in this fast pace for this booming sector. The Draft Bill is essentially concerned with regulating medical devices as a separate category. The Bill is focused for the industry as there was a need to regulate the online Pharmacies, Clinical Trials and Investigations along with stringent penalties and punishments to complete the prevalent space in the healthcare laws and regulations. Though there are some health experts who has noted it as regressive legislation it is yet to be seen how effectively it will regulate the booming healthcare industry.
