USFDA drug approvals at all-time high; Indian firms get 35-40% of nods

Source: Business Standard, Oct 13, 2018

Mumbai: The US Food and Drug Administration (USFDA) has granted the highest number of drug approvals in its history this year. The regulator has bettered last year’s numbers with 971 approval actions this year. This includes 781 final nods and 190 tentative go-aheads.

Indian firms account for 35-40 per cent of the global nods. Analysts feel that rising rate of approvals would on one hand increase competition in the US generic market, and on the other allow new players to enter.

However, analysts expect the growth in approvals to flatten as the number of filings has seen a dip in FY18. This is not expected to rise substantially in the coming years. Read the rest of this entry »

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Import norms relaxed for certain chemicals used in pharma sector

Source: The Hindu Business Line, Oct. 03, 2018

New Delhi: The government on Wednesday relaxed import norms for about 34 chemicals used in pharmaceuticals industry, a move which would ease inbound shipments of these items.

The import policy of 34 items “has been revised from restricted to free subject to no objection certificate from Narcotics Commissioner, Gwalior , before import of the item”, the Directorate General of Foreign Trade (DGFT) said in a notification.

The chemicals include cocaine, norephedrine, cathine and its salts, ephedrine hydrochloride and concentrates of poppy straw, nicotinic acid and aminorex.

Make it large—a significant trend in the Indian pharmaceutical industry

9Source: LiveMint.com, Sept 25, 2018

The pharmaceutical sector recorded deals worth over $2.1 billion so far in 2018, compared with $1.9 billion across the 12 months of 2017. The spike in activity could be attributed to Aurobindo Pharma Ltd’s agreement to acquire the dermatology business and three manufacturing units of Sandoz for $1 billion, which is the largest outbound deal by an Indian pharmaceutical company.

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Soon, uniform inspection norms for pharma units

Source: Business Standard, Sept 20, 2018

Mumbai: There may soon be uniform regulatory standards for manufacturing units of the pharmaceuticals industry in the country as the government gets ready to join the Pharmaceutical Inspection Cooperation Scheme (PICS). The government is trying to implement a uniform inspection standard, calling it the Indian Good Manufacturing Practices (GMP).

The PICS is an international instrument meant to improve cooperation in GMPs between countries and regulatory authorities.

About 7,000-odd small and large pharma manufacturing units, about 80 per cent of the industry, in India do not follow World Health Organization (WHO) GMPs. These would find it difficult to comply with Indian GMPs as well.

Sources in the government and the industry said this could lead to consolidation among smaller units. The government is also mooting a cooperative manufacturing model for small units. Read the rest of this entry »

Health Ministry bans 328 fixed dose combination drugs

download (3)Source: The Hindu Business Line, Sept 12, 2018

New Delhi: The Ministry of Health and Family Welfare has prohibited the manufacture, sale or distribution of 328 fixed dose combinations (FDCs) for human use with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs, subject to certain conditions.

Earlier, the Central Government had, through its notifications published on the March 10, 2016 in the Gazette of India, prohibited 344 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940. Subsequently, the Government had prohibited five more FDCs under the same provisions.

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Aurobindo Pharma buys Sandoz’s US business in $900 million deal

Source: Business Standard, Sept 07, 2018

Mumbai / Hyderabad: In its largest overseas pharma transaction, Aurobindo Pharmaceuticals has announced the acquisition of Sandoz’s generic business in the US for $900 million.The deal gives the Hyderabad-based company access to Sandoz’s portfolio of oral solids and dermatology drugs and makes it the second-largest generic player in the US based on prescriptions. Aurobindo will raise a $900 million bridge loan from Japanese lender MUFG to fund the purchase. The company had a net debt-equity ratio of 0.3:1, which will increase to 0.6 :1 after the transaction.

In 2015, Lupin had acquired US drug maker Gavis in a $880 million deal, making it the largest outbound deal for an Indian pharma company. The Aurobindo-Sandoz deal eclipses that. Sandoz is a generic division of Swiss pharma giant Novartis.

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Over 340 ‘irrational’ drugs to go off shelves soon; many more under scanner

Source: Business Standard, Jul 26, 2018

Mumbai / New Delhi: The Centre is one step closer to banning 343 “irrational” fixed-dose combination (FDC) drugs that were potentially harmful to consumers. The market size of the banned drugs is estimated to be around Rs 20-22 billion and will impact the country’s top drugmakers.

Patient advocacy groups say more FDCs, worth Rs 200-250 billion, are under scanner. An FDC drug is one that contains two or more active ingredients in a fixed-dosage ratio. Read the rest of this entry »