'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.

Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.

Sources close to the development said the company had no further supply commitments to the WHO, and therefore, there was no suspension of any upcoming orders, reports Sohini Das.

Sources indicated that there were no fresh orders from the Government of India, and their supply commitments have ended as of March 31, reports Sohini Das.

No expecting mother ever needs to travel for more than 30 minutes to reach one of their hospitals, believes the Cloudnine group.

With intermittent disruptions in the supply chain of raw materials from China, the Indian pharma industry has braced itself with bigger inventory. Even smaller drug makers are now carrying a month of buffer stock of key raw materials, said industry insiders. The lockdown in various Chinese provinces, including Shanghai, is likely to delay shipments by two weeks to a month, said domestic players. Shipments are critical for the Indian drug industry, which imports 70 per cent of its raw material from China.

Adar Poonawalla says it took a five-minute chat with his father Cyrus before making the decision to manufacture Covishield. The bet paid off, and handsomely. Serum Institute now has the capacity to make 4 billion doses of Covishield annually.

The company had in December said that the CDSCO had approved a 12-month shelf life for Covaxin, which was nine months earlier, Sohini Das reports.

A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.

Serum Institute has the capacity to make 250 million doses of Covishield monthly.

'Someone may have diabetes, but at what level the disease qualifies as a comorbid condition is something a doctor will decide upon and certify accordingly.'

If the vaccine is recommended for use as a booster against Omicron, it may significantly boost the demand for Covishield in India.

As the Omicron variant of Sars-CoV-2 takes centrestage, vaccine makers in India are of the view that scaling up the existing vaccines to make them more effective is possible.

After ramping up production to meet the steep demand spike during the Covid-19 pandemic, Indian medical device makers are now struggling with idle capacity. According to industry estimates, around a third of the installed capacity, especially for consumables, disposables, small-ticket electronic items, etc., is lying unutilised. Sample this: India used to produce just 6.24 million pieces of PPE kits per annum before the pandemic, but by June this was ramped up to 233.87 million pieces per annum.

A nasal vaccine, one expert said, is a "fantastic idea" for two reasons -- one, it can potentially create sterile immunity, and two, it is easy to administer and thus scalable.

Will syringe shortage puncture India's Covid vaccine plans?

In September, Bharat Biotech aimed to supply 35 million doses, and take this up to 55 million by October. This is still less than what the Indian government expects from the company.