Pharma News Update – 22 September 2020

1.Acella Pharma recalls thyroid medications owing to their sub-potent nature :

Pharma news – 22 September: Acella Pharmaceuticals is voluntarily recalling two lots of thyroid medications owing to potency issues. As the reports from the USFDA^[1], the drugs being recalled are not strong enough and this has warranted the recall in the US.

The recalled lots include one containing 15 mg NP Thyroid Tablets and the other containing 120 mg NP Thyroid Tablets. These products contain only around 87 % of the labeled amount of levothyroxine.

Hypothyroidism or underactive thyroid is treated by using levothyroxine and liothyronine. Both these agents are called the active ingredients.

The FDA has announced that the symptoms of hypothyroidism return when sub potent drugs are used for treating underactive thyroid. The manifested symptoms include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss and swelling of the thyroid among others.

It further added that these drugs increase the risk of miscarriage and fetal hyperthyroidism when given to pregnant women. It also claimed that there is a serious risk of impairment to fetal neural and skeletal development when administered to newborn infants. Parallel to this, it induces toxic cardia manifestations like cardiac pain, palpitations and cardiac arrhythmias in elderly patients. These manifestations are also observed in those with underlying cardiac disease.

Till now, four reports of adverse effects have been received by the company. Medications that remain unaffected by this recall comprise those with “use by”, “discard after” or “expiration date” on or after December 2020.

The company is actively notifying its wholesalers to stop the distribution of these products. The same is also being done to the patients who are consuming these medications. However, patients are being requested to consult with their physicians before stopping the medication.

At the beginning of September 2020, around 483 lots of Nature-Thyroid and WP Thyroid were recalled by RLC labs. This was because these medications have as low as around 87 % of liothyronine or levothyroxine.

Abbreviations : 1. United States Food and Drug Administration

2.China raises the price of key starting materials used by the Pharma companies :

Pharma news – 22 September: In a recent tide of events, China has decided to hike the price of key staring materials (KSM) by 10 – 20 %. In contrast, the prices of active pharmaceutical ingredients (API) remain unchanged.

This change will significantly impact the Indian pharma as it majorly depends on China for both APIs and KSMs. These ingredients are widely used for manufacturing antibiotics, steroids and other medicines.

The rise in the cost is expected to pressurize the domestic market over the next few months. This price hike is also expected to discourage the indigenous production of API in India. Subsequently, it might even make manufacturing units unviable and APIs less competitive against the Chinese products at the global level.

Recent estimates have claimed that China supplies around 70 – 80 % of the basic raw materials needed for making medicines in India. The API needed for the manufacture of the popular painkiller paracetamol is also imported from China.

Per the Pharma Industry associations, the prices of APIs in China have surged by 25 – 30 % in the past three to six months. China has also supplied around 68 % of the $3.5 billion worth APIs imported by India in 2018-19. These APIs were used to manufacture several essential medicines by Indian drugmakers.