- Apprentice Lawyer
- Legal Jobs
On February 11, the Ministry of Health and Family Welfare issued a notification to broaden the scope of medical devices that are to be regulated under the Drugs and Cosmetics Act and the Medical Devices Rules.
“The novel coronavirus has killed hundreds of doctors, nurses and other health care workers around the world, hence leading to closure of various hospitals”.
The entire world is suffering from the global pandemic and medical staff is the most vulnerable to infection. The statistics highlighted above is an example of the debilitating situation.
Telemedicine is a boon in times like these. Even the World Health Organization (WHO) has suggested for digital healthcare as it actively protects healthcare workers by reducing non-acute patient-provider interactions, and assists communities in protecting high-risk individuals. Hence, Telemedicine is perfectly positioned to fight the epidemic.
Telemedicine is basically a novel, modern and far-reaching technique which may facilitate and provide state-of-the art medical care to people living in remote villages, far from even tertiary care centers.
It has long been a myth that our country does not have laws on Telemedicine and is not bolstered by the government machinery. However, recent legislations, notifications and government circulars are evidence to government preparedness for digital healthcare in India.
On February 11, the Ministry of Health and Family Welfare issued a notification to broaden the scope of medical devices that are to be regulated under the Drugs and Cosmetics Act, 1940 (DCA) and the Medical Devices Rules, 2017 (MDR).
It appears that the intention behind broadening the definition is to further hold medical device companies accountable for the quality and safety of their products, given the sophisticated functions that these devices are able to perform. This initiative is a stepping stone to the development of sound healthcare in India.
Medical Devices now to be treated as drugs
A drug is any natural or artificially made chemical that is used as a medicine. The Drugs and Cosmetics Act, however, defines drug to include devices intended for treatment of any type of disorder or disability thereof.
Medical devices, as mentioned in Schedule C of The Drugs and Cosmetics Act, 1940, did not find a safe space within the definition of drugs until very recently. Accordingly, on April 1, 2020 through an amendment in the Drugs and Cosmetics Act, 1940 medical devices are to be treated as drugs, within its original definition under Section 3(4)(b) and Medical Device Rules, 2017 .
Thus, out of 24 medical devices, which included cardiac stents, drug eluting cardiac stents, condoms, and intrauterine devices, the new amendment in the Act has increased this number by adding more devices such as needles, catheters, intraocular lenses, prosthetic replacements, ligatures, sutures, blood bags, nebulizers, blood pressure monitoring machines, and digital thermometers, among others. 37 devices are now to be treated as drugs with effect from next financial year.
This inclination of the government towards reviewing and amending acts like the Drugs and Cosmetics Act, 1940 helps us leap ahead of other nations in terms of providing better and effective medical services by way of the digital healthcare system. Effective quality control mechanisms have to be subjected to first two categories mentioned within 30 months from the enforcement of these new rules whereas the latter two categories will be subjected to a 42 months compliance regime to be effected.
Invigilating non-scheduled medical devices and drugs
The National Pharmaceutical Pricing Authority (NPPA) has taken up the task of monitoring the MRPs (Maximum Retail Prices) of non-scheduled medical devices. The main objective of this is to track if any importer/manufacturer increases its price beyond the accepted MRP, that is, ten percent during past twelve months. Moreover, with The Essential Commodities Act, 1955 in place, the liability of the manufacturer also extends to depositing the overpriced amount, if any, adding essentially the interest thereon. The legislative intent here is to ensure that no drug is overpriced and that a track of well-recorded information validates that all drugs are available at effective prices.
Another important projection of this amendment is towards widening the ambit of the definition so as to ensure the accountability and quality of such medical products, provided the complex functions that devices have to perform. This seems to also be in conformity with the set international norms and practices in line of regulation of medical devices. Also, this tracking method will brace the EHR (Electronic Health Record) for maintaining patients’ health records.
Data Privacy in the age of digital healthcare
The present amendment is an initiative to tackle the issue of accountability. However, another issue that has been constant is that of privacy. Privacy has been declared a fundamental right with conclusive, unambiguous and emphatic determination by the Supreme Court.
Any act intruding into the privacy of citizens has the tendency to create a totalitarian state, which would impinge upon democratic and constitutional values. Thus, the law needs to rectify and prevent such actions.
India’s health ministry on these lines has proposed a law to govern data security in the healthcare sector that would give individuals complete ownership of their health data. Individuals would have the absolute right to refuse or allow data to be used or discarded. And hospitals will be prohibited to use the data without consent. As per a press release issued last year on the proposed Digital Information Security in Healthcare Act (DISHA Act),
“The proposed legislation is harsh on prowling data poachers with stringent punishment that entails five years imprisonment and a fine of Rs. five lakhs”.
This would make India one of the world’s foremost jurisdictions in the regulation of healthcare data to keep check on data poachers and privacy intruders.
However, every action of the government is not free from privacy infringement. Even as Aarogya Setu was launched as a one-stop solution during the COVID-19 pandemic, there have been multiple privacy concerns surrounding it. Of this vacuum is not urgently cured, it will become a blot on entire initiative of digital healthcare, which actually can do wonders in improving health and combating the pandemic.
India has been suffering from a staggering toll of ill health from communicable diseases and COVID is one amongst those deadly diseases. However, stewardship of government has largely been able to curb the menace and successive policy decisions are continuing to curb the menace.
Telemedicine is a major new development of these policies. It is proving to be feasible and suitable to India. It is intrinsically not the safest measure but can be seen as a viable measure to prevent situations like COVID-19.
Telemedicine is here to stay and is likely to play an increasing role in future healthcare. If it were to be adopted widely, it might have a considerable impact on the national health services. However, if the government machinery fails to protect data privacy, it will be a blot on the entire concept. Privacy breaches can be prevented if proper legal deterrence is created by the government, which is possible only via a national legislation on Telemedicine, including a proper framework defining rights and a penalty mechanism.
The black and white lettered law actually prevents ambiguity and creates effective deterrence which our country urgently needs to reach the milestone of digital healthcare. But if these considerations are not taken up under the excuse of a health emergency and economic effectiveness, it would lead to an Orwellian state.
The authors are students of MNLU Nagpur.