The Centre has asked traders and resellers of medical devices to register in an attempt to expand the ambit of regulating the medical devices industry in the country. The move can have far-reaching consequences for both consumers and traders alike as products like face masks or prophylactics - now sold through grocers and other channels - may face issues of availability. In a notification dated September 30, the union ministry of health and family welfare said anyone wanting to sell, stock, exhibit or offer for sale or distribute a medical device, including in-vitro diagnostic medical device, will need a certificate of registration.
'This year there is a sharp spike in fever cases, and it seems to be more than the pre-COVID-19 levels.'
The transition of Class A and Class B medical device makers to the licensing regime by October 1 seems to be an uphill task with several small and medium manufacturers saying they are still awaiting the audit from the government authorities. If the licenses don't come through, either due to lack of audits or MSME units not clearing the audits, then a few thousand small-scale medical device units will face the issue of business continuity in three weeks. Class A medical devices are those with low to moderate risk to the patient or user (surgical dressings for example), while Class B medical devices refer to devices with moderate risks that require special controls (catheters for example).
Earlier this year, the Union Cabinet gave the management of state-run companies the freedom to decide on divesting their subsidiaries. However, the very next day a meeting was held at the top level of the Government of India, for the presentation of proposals for more autonomy for state-run companies. Interestingly, no chiefs of any of these companies were invited. It is a problem that will stare the government in the face with the state-owned banks too, as talks have again begun for inviting strategic investments in these companies.
This would be India's largest crowd-funded programme to help patients with a particular disease.
As many as 34 new drugs were added to and 26 dropped from an updated list of essential medicines on Tuesday, with the government saying this will reduce "patients' out-of-pocket expenditure". The National List of Essential Medicines (NLEM 2022) has 384 drugs, up from 376 in 2015. "Drafting this list is a lengthy process, and around 350 experts from across India have held over 140 consultation meetings to draft the NLEM 2022," Union Health Minister Mansukh Mandaviya said.
'Just put a patch on your arm and the vaccine can be absorbed by the body.'
'Gift-giving' - from free dinners and drug samples to promotional merchandise - seems to be driving drugmakers' marketing - a marketing prescription deeply entrenched in the industry. This is a well-oiled racket that sees pharmaceutical (pharma) companies 'gifting' doctors to push their respective drugs under the guise of marketing. But is there a cure in sight to end this unhealthy alliance? The recent controversy following the income-tax raids on Bengaluru-based drugmaker Micro Labs, makers of popular paracetamol brand Dolo-650, has brought this to the fore, again.
'The tie-up with Serum Institute Life Sciences brings to the table their strengths in manufacturing and also their vaccine portfolio.'
Way before the rains arrived at Talwandi Sabo Power plant in Punjab, the one check the coal ministry was carrying out was the availability of coal stock with the generator. Talwandi Sabo Power Limited (TSPL), the 1,980-Mw thermal power plant of Sterlite Energy, part of the Vedanta Group, which supplies about 15 per cent of Punjab's power, is one of the most difficult locations to manage coal supplies. It is nearly 1,700 km from the mines of Mahanadi Coalfields in Odisha, the longest coal route in India and possibly the trickiest as it cuts through the traffic heavy rail lines between Delhi and eastern India.
'We are trying to salvage 50-100 million doses of Covishield with the latest drive on booster doses.'
Bulk of the medicine sales in the $22-24 billion domestic pharma market happens through offline retail chemists. With the entry of online pharmacies, this space has started to witness a shake-up. Sample this: Dawaa Dost, a Rajasthan based digital health start-up, generates medicine orders from 'kirana' stores and women self-help groups (SHGs) that operate in villages, and then service these orders through its affiliated network of pharmacies. Biddano, another health-tech start-up, has a platform that acts as an aggregator for neighbourhood chemist shops.
India's medical devices imports surged 41 per cent to touch Rs 63,200 crore in 2021-22, led by a 48 per cent year-on-year (YoY) jump in imports from China to Rs 13,538 crore, the commerce ministry data analysed by the Association of Indian Medical Device Industry (AiMeD) has showed. Local industry players say this has led to several small and medium units to shut shop. Rakesh Vaid of Usha Fabs, a garments exporter, had started making N95 masks in his Gurgaon factory during the peak of the Covid-19 pandemic.
The central government has for the first time allowed a private company, Bajaj Healthcare, to process opium to extract alkaloids used to make pain-killers, cough syrups, and even cancer drugs. Two government factories in Ghazipur, Uttar Pradesh, and Neemuch, Madhya Pradesh, do the work yet, processing some 800 tonnes of opium gum annually to extract alkaloids. The government on Tuesday gave Thane-based Bajaj Healthcare an initial contract to process 500 tonnes of opium gum annually and wants production to be at 800 tonnes per annum (tpa) in the next five years, indicating the state's exit from the highly-regulated sector.
Overcoming its initial concerns, national reinsurer GIC Re has contributed to the formation of an insurance pool to cover most imports from Russia. While it will be called the fertiliser pool with a corpus of Rs 500 crore, it can be used to cover the risks of oil and gas imports too. This was decided by a clutch of Indian insurance companies, led by the state-owned ones. GIC Re's share is about 40 per cent in the pool. Last month, GIC Re had shot off a letter to all non-life insurance companies that underwrite marine risks not to ask it for reinsurance of cargoes that originate from Russia.
Pune-based Serum Institute of India (SII) is sitting on 200 million doses of Covishield that were manufactured in December and are set to expire in September. The company is likely to destroy these vaccines if nothing works out, Sohini Das reports.
'There will be ups and downs, and we have to plan how we live with it now.'
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
Medicine sales grew at a fast clip in smaller cities like Madurai, Meerut, Agra, and Varanasi in the last 12 months. The domestic pharmaceutical market, overall, has grown 12.3 per cent in this period, according to data from IQVIA MAT for April. MAT refers to the moving annual turnover or the turnover of the last 12 months. The data further showed that the top 30 cities contributed around 32 per cent to sales.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
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