Category Scan: Drug Shortages and Export Restrictions

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By: Beroe Inc --

22 March, 2020

Category Scan: Drug Shortages and Export RestrictionsHighlights: As China continues to contain the CoVID-19 outbreak, the tension has reduced among global pharma players. China has started reopening its pharmaceutical operations in Wuhan under strict safety measures.  Measures undertaken by Government bodies to tackle drug shortage EU:  Europe has not reported any API or drug shortage, however, the EMA are closely monitoring the impact of corona outbreak in affected regions. European players have enough inventory for next three months. APAC:  Indian pharma companies have declared that there are no supply shortages in India, and thereby  are requesting the Indian government to lift ban on export restrictions. Department of Pharmaceuticals  has formed a committee to regularly monitor the availability of pharmaceutical ingredients and raw materials.  Impact on API Prices: On an average, API prices have increased 10-15 percent. However, in some cases, the increase has been more than 50 percent  Ex: 50 percent hike – Paracetamol prices were as Rs 250-300 kg in Jan 2020 to and is at 400-450/kg in March) 52 percent hike - Montelukast sodium’ (an anti-asthma drug) is trading between Rs 52,000 and Rs 58,000 per kg, compared with Rs 33,000-38,000 per kg a few months ago 40 percent hike - Penicillin has increased to Rs 639 per unit against Rs 454 per unit in January
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drugs shortage

 

As China continues to contain the Covid-19 outbreak, the tension has reduced among global pharma players. After a break of nearly two months, China has restarted its pharmaceutical operations under strict safety measures.

Measures undertaken by Government bodies to tackle drug shortage

EU:

Europe has not reported any API or drug shortage, however, the EMA are closely monitoring the impact of corona outbreak in affected regions. European players have enough inventory for next three months.

APAC:

Indian pharma companies have declared that there are no supply shortages in India, and thereby  are requesting the Indian government to lift ban on export restrictions. Department of Pharmaceuticals  has formed a committee to regularly monitor the availability of pharmaceutical ingredients and raw materials.

Impact on API Prices

On an average, API prices have increased 10-15 percent. However, in some cases, the increase has been more than 50 percent.

  • 50 percent hike – Paracetamol prices were as Rs 250-300 kg in Jan 2020 to and is at 400-450/kg in March).
  • 52 percent hike - Montelukast sodium’ (an anti-asthma drug) is trading between Rs 52,000 and Rs 58,000 per kg, compared with Rs 33,000-38,000 per kg a few months ago.
  • 40 percent hike - Penicillin has increased to Rs 639 per unit against Rs 454 per unit in January.

Supplier News

  • Sun Pharma, a key supplier, has almost doubled the price of Azithromycin due to the supply shortage.
  • Auromedics (U.S. subsidiary of Aurobindo Pharma) faces supply shortage of bupivacaine injection, as piperacillin, a KSMs supply is disrupted. This might affect the price of Bupivacaine shortly.
  • Wuxi’s  facility for discovery services in Wuhan has resumed production. WuXi AppTec has now resumed operations at all facilities in China post opening of its Wuhan facility.

Drug Shortages and Export Restrictions

Drug Shortage

  • U.S.: On 27 Feb 2020, FDA released a statement on the impact of COVID-19 on the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.
  • FDA has alerted the shortage of a human drug, but has not revealed the name of the drug or the manufacturer. The shortage is reported to be due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug.
  • FDA has also identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China.

Export Restrictions

  • On 03 March 2020, Government of India published an amendment restricting the exports of 13 APIs along with some of their finished formulations.
  • Most of the APIs in the list are manufactured in limited quantities in India or highly dependent on China.
  • For example, Export restriction on Paracetamol is mainly due to the shortage of the key starting material para-amino phenol (PAP). China’s supply of PAP has reduced dramatically and prices have also increased.

Export Restriction on Active Pharmaceutical Ingredients

Paracetamol

Progesterone

Tinidazole

Chloramphenicol

Metronidazole

Neomycin

Acyclovir

Erythromycin Salts

Vitamin B1

Clindamycin Salts

Vitamin B6

Ornidazole

Vitamin B12

 


Sources:

  1. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update
  2. https://dgft.gov.in/sites/default/files/Noti%2050_0.pdf
  3. https://www.pharmacompass.com/radio-compass-blog/covid-19-india-restricts-drug-exports-amid-rising-prices-of-essential-bulk-drugs-fda-announces-first-drug-shortage