Chinese firms resume export of pharma inputs to India

Source: The Hindu Business Line, Mar 25, 2020

New Delhi: In what could be good news for Indian drug makers, the import of active pharmaceutical ingredients (APIs) and other raw materials from China has resumed.

Following the outbreak of Covid-19 in China, export of raw materials from that country to India was disrupted as most manufacturers ceased operations.

“The import of raw materials from China commenced about 10 days ago and we are now receiving them from all provinces except one,” R Uday Bhaskar, Director-General,

Pharmaceutical Export Promotion Council (Pharmexcil), told BusinessLine on Wednesday.

India imports about $2.5-billion worth of APIs from China, according to Pharmexcil data. The industry had earlier expressed concern over the disruption of imports from China and said the existing inventory would be adequate to run production for up to three months.

A Pharmexcil official said that the resumption of imports was a good development.

Logistics concerns

Chinese manufacturers have also conveyed their readiness to supply to India personal protection equipment that will be crucial in fighting the Covid-19 contagion. “We have been approached on this by China only yesterday and are working on it,” he said.

However, the state of internal logistics and the inability to move shipments are a concern.

Both for import of raw materials from China, and pharma exports, the lockdown has been a challenge, with cancellation of all flights, suspension of operations at ports, and trucks off roads. “Most of the exports have not been lifted from airports and ports from the beginning of this month. Restrictions on pharma exports are also matter of worry for the industry now,” said a senior functionary of a leading Hyderabad-based pharma company.

Tamil Nadu to set up Pharmaceutical Ingredients Park with Rs 770 crore

Source: Business Standard, Mar 24, 2020

Chennai: Tamil Nadu government has announced setting up of an Active Pharmaceutical Ingredients (API) Park in the state, with an investment of around Rs 770 crore amidst coronavirus menace. The state government also announced Rs 3280 crore to support the people who are suffering from the virus outbreak.

The new API Park to manufacture bulk drugs that would be used for finished dosages, will be set up in around 650 acre land in Cheyyar, in Thiruvannamalai district with basic amenities such as warehouses, research and development and waste treatment facilities, with an investment of Rs 770 crore, said State Chief Minister Edappadi K Palaniswami today.

The move comes at a time when the coronavirus outbreak in China has raised concerns about availability of critical and essential bulk drugs to produce finished formulations of life saving medicines. The country is currently dependend on APIs from China for various such medicines, and disruption in availability of APIs was a concern for the industry and the public health experts.

The state government has also allocated around Rs 110 crore to set up coronavirus special facilities in various cities and upgrade the King Institute of Preventive Medicine & Research, Guindy, to a Bio Safety Level III centre.

It has also allocated Rs 3280 crore to support those who lost their livelihood due to restrictions over coronavirus in the state. It will be providing Rs 1000 to each ration cards which are eligible for rice and other food grains from the Public Distribution System. People who are working for daily wages, such as auto rikshaw drivers, construction workers etc will get Rs 1000 each along with 15 kg rice, one kg pulses and one kg of cooking oil. The state government has said that six more people were tested positive, taking the total number of positive cases to 15. A total of 2,09,163 passengers were screened at the Airports of Chennai, Trichy, Madurai and Combatore and 15,298 are under home quarantine, while 43 aymptomatic passengers from highly affected countries are being quarantined in facilities near airport and 116 are under hospital isolation.

Govt approves Rs 13K-crore package to boost bulk drugs manufacture

Source: Business Standard, Mar 21, 2020

Mumbai: The Union government on Saturday approved a package comprising four schemes with a total outlay of Rs 13,760 crore to boost the domestic production of bulk drugs and medical devices and exports.

The Union Cabinet chaired by Prime Minister Narendra Modi approved outlay of Rs 9,940 crore and Rs 3,820 crore for bulk drugs and medical devices, respectively, Minister of State for Chemicals and Fertilizers Mansukh Mandaviya told reporters.

The Cabinet also approved a sum of Rs 3,000 crore for the next five years for a scheme to promote bulk drug parks and for financing common infrastructure facilities at three such parks, he added.

A sum of Rs 6,940 crore has been approved for the Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical key starting material (KSM), drug Intermediates and active pharmaceutical ingredients (APIs), Mandaviya said. The PLI scheme will lead to expected incremental sales of Rs 46,400 crore and significant additional employment generation over eight years, he added.

The plan is to develop three mega bulk drug parks in partnership with states. The Centre will provide grants-in-aid to states with a maximum limit of Rs 1,000 crore per park.

Financial incentive will be given to eligible manufacturers of 53 identified critical bulk drugs on incremental sales over the base year (2019-20) for a period of six years. Of these drugs, 26 are fermentation-based bulk drugs and 27 are chemical synthesis-based bulk drugs. The rate of incentive will be 20 per cent (of incremental sales value) for fermentation-based bulk drugs and 10 per cent for chemical synthesis-based ones.

Meanwhile, the scheme for promotion of medical device parks will provide a maximum grant-in-aid of Rs 100 crore per park to states. It will have financial implications of Rs 400 crore, Mandaviya said.

“The PLI scheme for promoting domestic manufacturing of medical devices with financial implications of Rs 3,420 crore,” he added. The expenditure to be incurred for the schemes on promotion of medical devices will be for the next five years.

Under the sub-scheme for promotion of medical device parks, common infrastructure facilities would be created at four parks, which is expected to reduce manufacturing costs.

“It will lead to expected incremental production of Rs 68,437 crore over five years,” he said.

He added the schemes have potential to generate an additional employment of 33,750 jobs over five years and reduce import of target segments of medical devices.

However, even as the government gears up to reduce import dependence for pharmaceutical raw material and medical devices, the sector said the immediate focus should be on utilising existing capacities.

Yogin Majmudar, a bulk drug unit owner and head of the bulk drug committee of the Indian Drug Manufacturers’ Association (IDMA), said in the scheme, the support to be extended to brownfield units was not clear. “There can only be an immediate increase in production from these units. Parks are a longer-term solution with a horizon of a minimum of three years,” he said.

Around 40 per cent of installed capacity is estimated to be lying idle, he said.

Majmudar added that environment regulations needed to be tweaked to get faster approvals. The focus should have been on effluent quality and quantity and not on the product portfolio of an API unit. In the announcement there was no mention of that, a major hindrance to quick production, he said. Rajiv Nath, forum coordinator of Association of Indian Manufacturers of Medical Devices, said, “We are more than hopeful that these schemes announced would help boost local manufacturing and will accelerate medical devices manufacturing as a ‘Make in India’ enabler, make quality healthcare accessible and affordable for common masses, enable placing India among the top five medical devices manufacturing hubs worldwide and help end the 80-90 per cent import dependence forced upon us and an ever increasing import bill of over Rs 38,837 crore”.

Govt allows pharma formulations exports under export-linked scheme

Source: The Economic Times, Mar 20, 2020

NEW DELHI: The government on Friday allowed the exports of 13 formulations including those made of Vitamin B6, B12 and B1 under advance licenses issued on or before March 3. It also permitted exports of the restricted 13 active pharmaceutical ingredients (API) and 13 formulations is allowed from units in special economic zones (SEZ).

The Directorate General of Foreign Trade (DGFT) had restricted the exports of 26 active pharmaceutical ingredients (API) and formulations on March 3 to ensure there is no shortage of drugs in India due to the lockdown in China’s Hubei’s province, a major source for these raw materials that has also been the epicentre of the coronavirus outbreak.

“DGFT has revived various representations from exporters highlighting the issues faced by them in
fulfilling their export obligations under Advance Authorisation scheme,” the directorate said in one circular.

Under an advance license, duty-free imports are bound to certain export obligations. The Department of Pharmaceuticals had written to the DGFT to allow exports from APIs imported under an advance licence.

“Also, no enhancement of quantity shall be permitted for import and export items in these advance licenses,” DGFT said. However, paracetamol, Vitamin B6, B12 and B1 continue to remain restricted.

In another circular on exports from SEZs, it said the earlier restriction was applicable only to those item descriptions specified and not products that may fall under the same tariff code but have different description.
The government had restricted the exports of paracetamol and vitamins B1, B6 and B12, tinidazole, metronidazole, acyclovir, progesterone, chloramphenicol, erythromycin salts, neomycin, clindamycin salts and ornidazole amid the ongoing coronavirus pandemic.

Govt restricts exports of 26 active pharma drugs, formulations

Source: Business Standard, Mar 03, 2020

New Delhi: Exports of certain APIs and formulations, including Paracetamol, Vitamin B1 and B12, have been put under restricted category amid the coronavirus outbreak in China, according to a government notification on Tuesday.

Now, export of 26 active pharmaceutical ingredients (APIs) and formulations require licence from the directorate general of foreign trade (DGFT).

“Export of specified APIs and formulations made from these APIs …is hereby restricted with immediate effect and till further orders,” the DGFT said in the notification.

India on Monday reported two new cases of the novel coronavirus, including one from the national capital. The outbreak has killed more than 3,000 people globally.

Indian Pharma industry has only 2-3 months stock of Chinese APIs

Source: The Hindu Business Line, Feb 18, 2020

Describing the situation in terms of raw material import from China as “grim,” India Pharmaceutical Alliance (IPA) said the Indian Pharma Industry has enough stocks of active pharmaceutical ingredient (APIs) for two to three months only.

Speaking on the sidelines of BioAsia 2020, IPA Secretary General Sudarshan Jain said they were in touch with the Centre, seeking faster environmental clearances for some of the API manufacturing units so that dependence on China was reduced.

According to Jain, India imports ₹17,000 crore worth of APIs from the Novel Coronavirus-hit nation. Read the rest of this entry »

Medical devices to be treated as drugs from the next financial year

Source: Business Standard, Feb 12, 2019

Mumbai: Come April 1, all medical devices sold in the country would be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940, the ministry of health and family welfare said in a notification on Tuesday.

At present, only 23 medical devices have been classified as drugs. Of these, only a few including cardiac stents, drug eluting cardiac stents, condoms, intrauterine devices, have been brought under price control.

The health ministry said the decision was taken after consultation with the Drugs Technical Advisory Board (DTAB), the apex decision making body on technical matters related to drugs. Read the rest of this entry »