Draft labelling rules for prescription drugs unveiled

Source: LiveMint.com, Nov 14, 2017

New Delhi: Antibiotics and other prescription drugs must come in packages with warnings printed inside a red rectangular box, the health ministry has suggested in its latest labelling rules aimed at checking antimicrobial drug resistance in India.

Prescription drugs are those that require a medical prescription to be dispensed, unlike over-the-counter drugs.

The ministry had earlier proposed a conspicuous red vertical band running throughout the body of the package with the words “schedule drug” printed on it. However, the regulatory body on drugs and devices—the Central Drugs Standard Control Organisation (CDSCO)—put out a draft notification on its website on Monday with new labelling rules seeking comments and suggestions from stakeholders.

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Intas closing in on Mallinckrodt’s US generics business

Source: The Economic Times, Nov 02, 2017

MUMBAI: Intas Pharmaceuticals, backed by Temasek and ChrysCapital, has inched closer to arguably the biggest cross-border buyout by an Indian pharma company, emerging as the front-runner to acquire Mallinckrodt’s generics drug business in the US for $1.5 billion, said people close to the ongoing discussions.

A successful transaction will give Intas — the largest privately held pharmaceutical company in India with an annual turnover of over $1 billion and a valuation almost twice that — access to the attractive therapeutic segment of controlled substances or opioids that have steep entry barriers and high margins.

This comes as US President Donald Trump has declared opioid addiction a public health emergency in the US and drugmakers have found themselves under scrutiny for allegedly contributing to the crisis.From an initial shortlist of five that had seen private equity firms compete with Chinese competitors, only two were considered for the final rounds of negotiations. The present discussions are largely centred around indemnity clauses, said the people cited above.
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Govt moves to finalize methodology to fix prices of new drugs

Source: LiveMint.com, Oct 30, 2017

The government has initiated the process to finalize a new methodology to fix the prices of new drugs amid concern over delays in approving prices, a pre-requisite for launching a new drug.

The government is considering doing away with the present practice of deciding a new price for each applicant of “new drug”, according to people in the government who are privy to the development.The department of pharmaceuticals (DoP) under the chemicals ministry has called a meeting with industry representatives on 31 October to discuss the proposed changes in the Drug Prices Control Order (DPCO) 2013.

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Govt readies policy to regulate online pharmacies

Source: LiveMint.com, Oct. 17, 2017

New Delhi: The government plans to regulate the sale of medicines through online pharmacies, a proposal that is opposed by chemists on the grounds that online sales are illegal and easy availability of drugs can lead to their misuse.

The Central Drugs Standard Control Organisation (CDSCO), the regulator for pharmaceuticals and medical devices in India, and the health ministry have initiated discussions to frame a policy that will facilitate access to quality medicines and encourage more entrepreneurs to sell medicines online.

While as many as 50 online pharmacy start-ups sell medicines over the internet in India, the government’s proposal to regulate the market will give a stamp of official approval and remove uncertainties surrounding the legality of such sales.

The government plans to set up an electronic platform that will act as the nodal platform to monitor the movement of medicines. “The supply of any drug shall be made against a cash or credit memo generated through the electronic platform and soft and hard copies of memos shall be maintained by the licencee,” said the first draft of the proposal to regulate e-pharmacies. Mint has reviewed the document.

Officials working on the draft rules under the Drugs and Cosmetics Act have categorized drugs into five schedules ranging from medicines that have limited risk to those that have a greater potential to be abused. The third schedule carries all over-the-counter drugs; the fourth schedule will carry all prescription drugs; the fifth schedule will have antibiotics and anti-bacterial drugs; the sixth will deal with narcotics and psychotropic drugs; and the seventh will cover any medicines that do not fall under the other schedules. There are no first or second schedules.

It will however not be easy to buy refills and repeat orders online, according to the draft proposal. Antibiotics, antibacterial drugs and narcotics and psychotropic drugs shall not be dispensed “more than once” unless so prescribed.

“If the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals, it shall not be dispensed otherwise than in accordance with such directions,” said a government official privy to the development. At the time of sale, pharmacists will also have to maintain a record with the name and address of the seller and the date on which the prescription is dispensed.

The government is also considering that pharmacists after dispensing medicines stamp the prescription as “dispensed” and record the data for drugs or substances specified under the fifth or sixth schedule so that attempts at unauthorized use of the same prescription triggers an alert. For drugs under the fifth or sixth schedule, the patient should be registered on the website with their name, address and Aadhaar number.

To ensure safety, for drugs specified under the fourth, fifth and sixth schedules, the cash or the credit memo will contain the name of the doctor, their registration number and the patient’s address. “The rules are still under the discussion stage. We are planning to regulate the business in a phased manner after taking those in business on board,” another government official said.

Dharmil Sheth, co-founder of medicine delivery app Pharmeasy, said that rules are needed to enable a friendly environment for both online and offline retailers. “We cannot have different rules for every stakeholder. With the evolution of the internet and GST, there should not be any restriction on inter-state sale.”

Patented drug launches help MNCs score over Indian peers

Source: The Economic Times, Sept 12, 2017

MUMBAI: At a time when the pharmaceuticals industry is facing the heat with price cuts and regulatory issues in the country, multinational companies are growing faster than their domestic peers due to better product mix, says a study.

While Indian companies still control almost 80% of the Rs 1 lakh crore pharma market in the country, the strategy of launching specialised patented product is helping multinationals grow much faster in India, a report released by market research firm AWACS has said.

While the overall Indian pharma companies registered 1.4% year-on-year growth in August, MNCs clocked 6.2% growth during the month, led by companies such as AstraZeneca, Janssen and Boehringer Ingelheim on the back of their brands Glycomet, Invokana, and Jardiance, respectively, the study said. Read the rest of this entry »

Govt’s proposed pharma marketing rules hit legal roadblock

Source: LiveMint.com, Aug 24, 2017

Mumbai: India’s plan to bring in marketing rules to curb unethical promotional practices in the country’s drug industry faces an indefinite delay after it hit a legal roadblock, marking a setback for public health groups.

The country’s law ministry has rejected draft marketing rules, which were prepared by the Department of Pharmaceuticals (DoP) after nearly two years of deliberations, saying they cannot be passed under the proposed legal framework, industry sources told Reuters.

DoP officials did not respond to requests for comment, and G.N. Raju, secretary at the law ministry’s legislative department declined to comment beyond saying that the ministry had responded to the DoP on the draft weeks ago.

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Govt plans bulk drugs parks, import curbs to boost manufacturing in India

Source: LiveMint.com, Aug 21, 2017

New Delhi: In a bid to revive India’s active pharmaceutical ingredient (API) and bulk drug market, the government is contemplating restrictions on the import of APIs and has suggested setting up of mega bulk drug parks, a move that is expected to boost domestic production.

In the draft pharmaceutical policy framed by the department of pharmaceuticals under the ministry of chemicals and fertilizers, the centre has proposed “peak customs duty” for all APIs that can be indigenously manufactured.

Bulk drugs or APIs are the active raw materials used in a drug that give it the therapeutic effect. “All APIs which can be indigenously manufactured should be imported at peak customs duty,” said the draft policy, reviewed by Mint.

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