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Maharashtra redoubles efforts to combat COVID-19

Shardul Nautiyal, Mumbai
Thursday, December 31, 2020, 08:00 Hrs  [IST]

Even as COVID-19 has hugely disrupted the global healthcare services, the Maharashtra Food and Drug Administration (FDA) has taken a slew of initiatives to contain the deadly pandemic, ranging from price capping of masks in the country for the first time even when the National Pharmaceutical Pricing Authority (NPPA) has yet to notify it, crackdown on unethical marketing of hand sanitisers and masks and promoting production of medical grade oxygen for COVID patients in state.

According to a report, the cash-strapped state government has made available an additional Rs 1,617 crore from the annual district plan for tackling the pandemic. According to an official order promulgated by the planning department, led by deputy chief minister Ajith Pawar, 16.5 per cent of the fund allocated for each district will have to be utilised exclusively to boost the healthcare infrastructure.

Alarmed by the state’s critical financial situation, the government, on May 14, had imposed a 67 per cent cut on budgetary provisions for the financial year 2020-21 to mobilise Rs 70,000 crore for the healthcare sector. So, against the provision of Rs 9,800 crore for each of the 36 districts, the planning department had imposed stringent restrictions on utilisation of funds, as a result only Rs 3,234 crore was available. Subsequently, provisions for most developmental schemes were either scrapped or drastically cut.

The department has now said that funds for the annual district plan will be available as per the 2020-21 budgetary provisions, but, 16.5 per cent will have to be used exclusively for strengthening the measures taken by the public health and medical education departments. District collectors and health officers have been tasked with ensuring that the funds are used only for strengthening the healthcare infrastructure, the report added.

The state Chief Minister, Uddhav Thackeray, recently held an online meeting with the divisional commissioners, district collectors and municipal commissioners to take stock of the COVID situation. He had asked them to increase the number of tests and step up anti-COVID measures in the backdrop of the new COVID variant isolated in the UK. Public health minister Rajesh Tope, who was part of the meeting, said the health system would increase surveillance. He has also instructed district collectors to ensure the supply of oxygen is maintained and the daily number of RT-PCR tests are increased.

The Maharashtra government has formed a task force to manage the distribution of COVID vaccine and how vaccination will be carried out in the state, the Chief Minister said recently.

According to an official statement, “A task force has been set up to manage the distribution and vaccination in Maharashtra and the government is in constant touch with Adar Poonawalla of the Serum Institute of India to track development of the coronavirus vaccine”.

The World Health Organization (WHO) has praised the efforts made to contain the spread of COVID in Dharavi, one of the world’s largest slums, underscoring the need for community engagement to turn the pandemic around.

Five-point action plan
The state government had earlier unveiled a five-point action plan to fight against it. Uddhav Thackeray had detailed five steps in the areas of health, migrants, economy, agriculture and day-to-day administration.

On the health side, the CM informed that the state government has designated COVID and non-COVID medical facilities separately and named 17 governments and 15 private VDRL labs.

A special task force with a panel of specialist doctors has been formed to minimize the death rate and treat critically ill covid-19 patients.

The state has also appointed experts for dialysis, cardiac arrest and diabetes at COVID hospitals. In addition to procuring personal protective equipment (PPE) and ventilators, the government has started sanitizer production.

To identify contact-tracing cases, the state has started home-to-home testing in the containment zones, the health action plan said.

Medical oxygen
The Maharashtra FDA has recently issued licenses to seven more manufacturers of industrial oxygen to produce medical oxygen for COVID patients taking the total count to 73 manufacturers.

The state drug regulator recently sent across a directive to all the industrial gas manufacturers in the state to produce medical grade oxygen to cater to the growing demand for treating critically ill COVID patients in the country.

Besides this, Maharashtra FDA officials have maintained that there is adequate quantity of medical oxygen available in the state.

“There are 20084 oxygen cylinders available in the state with an estimated oxygen quantity of 1,40,589 cubic metres with oxygen available in bulk at 83,63,732 cubic metres,” according to J B Mantri, joint commissioner (HQ), Maharashtra FDA and state drug controlling authority.

More licenses are likely to be issued as Maharashtra FDA has outlined a plan to help manufacturers take up production of medical oxygen on war footing.

Drugs Controller General of India (DCGI) had earlier directed state licensing authorities (SLAs) to urgently grant permission to manufacturers of industrial oxygen to manufacture medical oxygen in the light of COVID-19 outbreak.

Supplemental oxygen therapy is a part of the clinical management of COVID-19. It is the use of oxygen as a medical treatment. This also includes supplementing oxygen for low blood oxygen, carbon monoxide toxicity, cluster headaches and to maintain enough oxygen while inhaled anesthetics are given.

All India Industrial Gases Manufacturers’ Association (AIIGMA) has been proposing to allow manufacturers of industrial oxygen to manufacture oxygen for medical use.

As per the DCGI directive to the SLAs, it has been decided in public interest that the premises which are having facility to manufacture industrial oxygen should be granted manufacturing license to manufacture oxygen for medical use within 24 hours of the submission of application and fees as per the Drugs and Cosmetics (D&C) Act. An undertaking needs to be furnished in writing to manufacture medical oxygen in compliance with standards prescribed in Indian Pharmacopoeia and labeling requirement as per the D&C Act and Rules.

“SLAs are requested to take action in public interest to grant permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in light of COVID 19,” DCGI stated.

Crackdown on unethical marketing
In its crackdown on unethical marketing of hand sanitisers and masks, the state FDA seized stock worth Rs1.80 crore hand sanitisers and masks based on 10,339 inspections over the past few months during the lockdown period.

The state drug regulator also resolved many cases of non-compliance to Essential Commodities (EC) Order and Drugs and Cosmetics (D&C) Act based on calls at Toll free number 1800222365 and 022 26592362/ 26592263/ 26592365.

Maharashtra FDA has also appealed to the citizens to report all issues related to unavailability of medicines and black marketing of essential drugs and products at the toll-free numbers.

The Central government had notified EC Order, 2020 to regulate the production, quality, distribution and logistics of masks (2ply and 3ply surgical masks, N95 masks) and hand sanitisers for COVID management. It was widely reported that the key ingredient to manufacture hand sanitiser like isopropyl alcohol (IPA) was being sold at exorbitant rates due to black marketing and creating artificial shortages.

The state regulator also conducted 54 raids on firms and seized hand sanitisers and masks worth Rs. 1.77 crore based on 8,033 inspections in the past. The FDA officials have maintained that they are keeping a strict vigil to maintain adequate supplies of hand sanitizers, masks and medicines in the state.

At present, alcohol-based hand sanitisers are the only known means for rapidly and effectively inactivating a wide array of potentially harmful microorganisms on hands.

Curbing overcharging of masks
To keep an oversight on violations in sale of face masks, the Maharashtra (FDA) has directed all drug inspectors (DIs) in the state to enhance inspections in wholesale and retail premises to curb overcharging following price capping notification of masks by the state government recently.

The Maharashtra government had recently notified prices of masks based on state government constituted expert panel report in consultation with Maharashtra FDA and mask manufacturers, Venus Health and Safety Pvt Ltd and Magnum Health and Safety Pvt Ltd. The panel was headed by former state health insurance CEO Dr Sudhakar Shinde.

Maharashtra FDA conducted 1945 inspections related to masks in the month of June and July with a major crackdown on establishments for selling N95 masks at exorbitant prices. It raided premises of establishments selling reputed brands of N95 masks at higher rates despite price control. Brands included Venus, Magnum and 3M, among others.

The Drugs Controller General of India (DCGI) had earlier asked manufacturers to voluntarily get registered on the CDSCO medical device online portal –cdscomdonline.gov.in to monitor the quality of masks in the country. The registration will secure the manufacturers a registration number from the CDSCO, which will, reportedly, also be a quality management system benchmark.

Maharashtra, the pharma capital
According to a report, Maharashtra, the financial capital of India can even be considered as the pharma capital due to many factors. The state is the key exporter of pharma products from the country.

Pharma destinations in Maharashtra are Pune, Nashik, Aurangabad and Mumbai/Thane. Tarapur is one of the preferred MIDC areas to house a large number of pharma enterprises. Maharashtra has a bio-pharma park (Serum Bio Pharma Park) at Pune. There are dedicated pharma special economic zones (SEZs) at Aurangabad and Nanded.

Even as India has the highest number of US FDA approved plants outside the US and Maharashtra has amongst the highest number of such plants in India due to availability of skilled manpower supply which is essential to maintain the international standards of manufacturing due to the strict regulatory guidelines.

Maharashtra has the ability to attract R&D investments in the new research areas and take appropriate steps to encash this opportunity.

Maharashtra besides being an investment-friendly destination has very good talent in the area of chemistry. Moreover, active pharmaceutical suppliers are centred in this region.

The state has amazing connectivity through airways, ports (MBPT & JNPT), 18 National Highways and has a strong railways network.

The production cost of medicines is 60 per cent lesser than the US and almost half of the Europe, 50 per cent lesser labor cost than the western countries, cost of setting up production plant is 50 per cent lesser than the western countries,

As far as waste disposition in concerned, Maharashtra has 20 operational CETPs in the state and another four are under construction. The state has four CHWTPs at Taloja, TTC, Ranjangaon and Butibori, which is one of the highest in the country.

Maharashtra is the first state to set up an independent Intelligence Branch with a separate wing to facilitate and speed up investigations under acts enforced by the FDA. The regulatory infrastructure in the state is of the highest order and the percentage of substandard drugs produced in Maharashtra is remote as compared to other states, the report added.

Despite being hit by the pandemic, Maharashtra has managed to keep the cases in check and bettered its health infrastructure as well.

 

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