The industry is looking to the government for quite a few answers.
The ministry had issued a draft notification to bring all medical devices under a single regulatory framework. The new definition for medical devices is aligned with that of the International Medical Device Regulators Forum, and CDSCO is the nodal authority. An ISO 13485 certificate of compliance is mandatory. At present, only 23 medical devices are regulated under the Drugs and Cosmetics (D&C) Act. The regulations are being worked out in consultation with the department of pharmaceuticals, Niti Aayog, the department of biotechnology, the Indian Council of Medical Research, the Bureau of Indian Standards, industry experts, and associations.
The National Essential Diagnostics List, finalized by the ICMR based on WHO’s EDL, is an attempt to provide guidance to the government for deciding the kind of diagnostic tests that HWCs and healthcare facilities in villages and remote areas require. In the highly fragmented diagnostic laboratories sector, with standalone centers accounting for 45–50 percent of the market, there are no published rates for most path labs – the test rates could vary from 50–200 percent of the actual test cost, without an assurance of quality.
As the Rs 6000-crore e-pharmacy industry is gearing up to Rs 27,000 crore of the highly fragmented Rs 4 lakh-crore Indian pharma market by 2020, the trade fraternity is dreading the ministry’s approval of the draft regulations recommended by the Drugs Technical Advisory Board. Apart from easy access to critical drugs, the online pharmacies are slowly becoming a new trading platform to route substandard and spurious medicines. E-pharmacies currently comprise only 2–3 percent of the India pharma market.
On the global front, compliance of plants of Indian pharmaceutical companies has once again become an issue with the FDA. Warning letters and observations have been issued to many companies having exposure to the US markets. This rise in regulatory hurdles is expected to impact product approvals and launches, and lead to a rise in remediation and compliance costs, thereby impacting revenues and EBITDA.
A tangled web indeed!