Medicines and medical devices are in existence for many years. Information and communication technology (ICT) has changed the way medicines and medical devices were sold in old times. Even medical devices have assumed a totally different identity with the introduction of smart technology and artificial intelligence. Now smart gadgets have connected individuals with hospitals, clinics and family doctors in a 24 x 7 x 365 mode. Health related data and information is available in real time to both doctors and the patients that has significantly improved the health of patients as remedial measures can be taken well in advance based on the data provided by smart e-health gadgets.
However, laws in India are lagging far behind and they are not compatible with the concepts like e-health, telemedicine, m-health, online pharmacies, etc. Further, India has still not enacted necessary dedicated laws for cyber security, privacy, data protection (pdf), online pharmacies, Ayurvedic preparations, etc without which Indian healthcare industry cannot grow and survive. Indian e-health and medical device manufacturers are also not complying with techno legal requirements like cyber law due diligence (pdf), encryption laws, etc. If we wish to incorporate e-health, m-health and telemedicine into a smart city model, then we have additional techno legal compliances that must be ensured.
Indian government is in the process of removing redundant and outdated laws and enacting new one as per contemporary requirements. Healthcare industry is also on the priority list of Indian government for legislative business. For instance, the Central Drugs Standards Control Organisation (CDSCO) is working towards drafting a new Drugs and Cosmetics Act, 2016 and a Medical Devices Act, 2016. The move follows after the ministry of health and family welfare initiated steps to revisit the D&C Act 1940 and Rules 1945. The objective of this step is to enact contemporary laws that can ensure safety, efficacy and quality of drugs and medical devices.
The director (Admin) of Central Drugs Standards Control Organisation (CDSCO) has on June 6, 2016 asked all state drugs controllers to give feedback based on their experience within 15 days from the said notice. There have been several transformations like new brands, biologicals and biotech drugs besides the fixed dose combinations that need a set of dedicated rules. These rules are also relevant keeping in mind the regulatory requirements of different countries where Indian medicines and medical and healthcare products are exported.
For instance, recently the United States Food and Drug Administration (U.S. FDA) issued an Import Alert 66-40 (pdf) titled Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs. This alert deals with detention without physical examination of drugs from firms which have not met drug good manufacturing practices (GMPs). Many Indian pharmaceutical companies have been listed on this alert and import from them has been banned. In fact, Lupin has recalled 9,210 bottles of Suprax drugs for failure to pass purity test.
Border enforcement of intellectual property rights (IPRs) by countries including Europen Union has also posed problem for Indian pharmaceutical and healthcare companies. EU and India even decided to sign a letter of understanding to protect off patent generic drug consignments. Further, due to policy decisions of United States, Novartis AG’s heart drug Diovan was also kept out of patients reach. This is despite the fact that Indian patent law is in conformity with WTO and international obligations. Expiring medicine Patents can boost pharmaceutical business and e-commerce as the generic pharmaceutical companies can provide affordable drugs in large quantity.
The Drugs and Cosmetics Act & Rules 2016 will try to ensure compliance with some of these issues by the Indian pharma industry. There is also the introduction of Central Licensing Authority (CLA) along with State Licensing Authority (SLA) and Central Licensing Approval Authority (CLAA) for Schedule III drugs in the last year’s Amendment Bill. The new regulations may also cover the Uniform Code for Pharma Marketing, Formation of Task Force to formulate bulk drug policy, medical devices policy, creation of price monitoring and resource units in the state drugs control department.