Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:
(a) whether it has been assessed from Indian Pharma Companies that there is no shortage of medicines in the country;
(b) if so, the details thereof and if not, the reasons therefor;
(c) whether any plan has been formulated to tackle the environmental challenges likely to be faced by the pharma industry; and
(d) if so, the details thereof?
MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS
(SHRI D.V. SADANANDA GOWDA)
(a) & (b): The Department of Pharmaceuticals (DoP) played a crucial role in ensuring the availability of essential drugs Generic or branded at reasonable prices before and during the COVID-19 pandemic. Timely and effective steps were taken to ensure no shortage of drugs during the lockdown period throughout the country. The National Pharmaceutical Pricing Authority (NPPA) under the DoP has taken various steps to ensure the availability of life saving essential drugs like Hydroxychloroquine, Paracetamol, Vaccines, Anti-Tuberculosis drugs, Anti-diabetic drugs, cardiac drugs, imported Anti-epileptic drugs and COVID-19 drugs like FDC Lopinovir & Ritonavir, Remdesivir, Favipiravir, Zinc Sulphate, Methylprednisolone, Enoxparin, Dexamethasone etc. Further, on the intervention of NPPA and DCG(I) manufacturers of Remdesivir have set up a Helpline to make available the Remdesivir. However, both these drugs are not part of Covid-19 Protocol and continue as part of investigational therapy Drugs.
To ensure seamless availability of drugs, the NPPA set up a ‘Control Room’ with Helpline No. 1800111255 and issues like Non-availability of medicines, masks, gloves, hand sanitizers etc., and price violation of medicines, masks, gloves, hand sanitizers, etc., were resolved promptly. Also, a COVID-19 dashboard on the NPPA’s website i.e.www.nppaindia.nic.in, having latest Office orders, circulars, helpline no., Email for sending grievances etc., was created for convenience of public and other stakeholders.
The NPPA ensured the availability of drugs by coordinating with State Health Authorities like SDCs and Central Govt. Authorities like the Central Drugs Standard Control Organisation (CDSCO), the Directorate General of Health Services (DGHS), Department for Promotion of Industry and Internal Trade (DPIIT) etc. The NPPA also collected the critical information from drug manufacturers for decision making to ensure drug availability.
The NPPA also coordinated issues related to production of raw material, medicines, medical devices, packaging material, etc. by manufacturers and movement of raw material, packing material, finished goods and manpower etc to ensure availability of life saving essential drugs during the lockdown.
The details of various steps taken by the NPPA are at Annexure 1.
(c) & (d): The Ministry of Environment Forest and Climate Change in consultation with the Central Pollution Control Board (CPCB) has notified discharge norms for pharmaceutical industries in January 2020 under the Environment (Protection) Act, 1986, a copy of which is at Annexure 2. These norms are reviewed and revised periodically. The notified norms are enforced by State Pollution Control Boards (SPCB) / Pollution Control Committees in the consent order (CTO-Consent to operate) issued under the Air Act (PCP), 1981 and the Water Act, 1974. Further the units are encouraged to reduce their waste water generation by technological advancement and reuse/recycle of wastewater.
All highly polluting 17 categories of industries, including bulk drugs and formulations (pharmaceutical) industry, have been directed to install online continuous effluent/emission monitoring systems (OCEMS). These OCEMS are connected to CPCB & SPCB. Based upon the SMS alert, industries are selected for manual monitoring. The CPCB, time to time carry out surprise inspection of the industries for checking performance and operational status of pollution control measures adopted by the industries. During the inspection/manual monitoring, if any industry is found non-complying the norms, then closure direction is issued under section 5 of the Environment (Protection) Act, 1986 to the unit for rectification or up-gradation of Effluent Treatment Plant (ETP)/ Air Pollution Control devices (APCDs).