USFDA observations beneficial in long run: Dr Reddy's India

Since November 2015, the company has significantly invested in processes, automation, detailed documentation of each batch and standard operating procedures and further strengthened its quality management systems.

Mumbai: US health regulator's observations are "unmistakably" beneficial in the long run and have helped the company accelerate the pace of quality reforms, pharma major Dr Reddy's Laboratories has said.

"The remedial actions triggered by the USFDA observations are unmistakably beneficial to us in the long run and it has helped us accelerate the pace of quality reforms across our plants. We believe that the shift in the US regulator's approach from 'what has gone wrong' to 'what can go wrong' is for the long term good of the industry," Dr Reddy's Labs Chairman K Satish Reddy said in the company's annual report.

Based on its corrective actions, the USFDA reinspected the company's three plants between February and April 2017. It had received some observations from the regulator thereafter and subsequently submitted a detailed response. The company is awaiting the USFDA's views on its latest set of responses.

Since November 2015, the company has significantly invested in processes, automation, detailed documentation of each batch and standard operating procedures and further strengthened its quality management systems.

However, the warning letter put on hold the company's approval of several key drugs, including high value added injectables and complex generics, to the US from the last quarter of 2015-16 and throughout 2016-17. This pipeline blockage affected revenues, margins and profits. Additional costs of conducting remedial work, including the use of international consultants, also reduced profits, he added.

Going forward, the drugmaker believes that the pricing pressures in the US market will be less severe and more calibrated in 2017-18. "We also have an excellent pipeline of complex generics to be introduced to the country in 2017-18 and expect to do better through this effective upgrade of our portfolio mix," Reddy said.

"We also believe that there are enormous opportunities across emerging markets and are playing actively to increase our presence in these territories through complex generics and biosimilars. The Russian and CIS markets are on a moderate upswing," Reddy added.

According to the pharma major, in the domestic market, threats of government-induced pricing pressure remain. "We are seeing greater offtake of generics - both relatively simple and complex - and oncological biosimilars, the latter through greater hospital and institutional sales. We believe that emerging markets will again get back to double-digit growth. Despite government induced pricing pressures on pharmaceutical products, India remains a high growth market," stated the report.

In 2016-17, revenues grew by 9 per cent over the previous year.

The first quarter of 2017-18, the chairman said, may see a temporary decline in sales due to de-stocking by trade on implementation of the Goods and Services Tax (GST). "Post normalisation, we expect to grow in low double digits in 2017-18 and for the foreseeable future," Reddy said.

Source: Economic Times India

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PHARMA NEWS | EMA Builds Collaboration with African Regulators

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

The European Medicines Agency (EMA) met with a delegation from the East African Community (EAC) from May 18–19, 2017 as part of the agency’s collaboration with African regulators. The meeting offered an exchange of information and discussion on the EAC potentially creating a networking medicines agency. The meeting followed a workshop held in March as part of EMA’s Article 58 procedure for drugs intended for use outside of the European Union.

EMA’s structure and operations were used as a model for the potential EAC networking medicines agency. Discussions at the meeting included drug approval processes, pharmacovigilance, inspections, training, and internal controls.

Participants in the meeting included heads of EAC national agencies, representatives from the World Health Organization, and representatives from the World Health Bank. The EAC is an official observer of the International Council for Harmonization and is a member of the International Pharmaceutical Regulators Forum.

Published under PHARMA NEWS

Source: pharmtech

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Australia's medicine labels are becoming clearer

When you buy prescription and over-the-counter medicines, sunscreens or vitamin supplements, you need important information to help you make an informed choice.

Medicine labels tell you what you are buying, what the medicine can do for you and how to use it.

What?

Why?

When?

Your labels?

 

What is changing under the new labelling rules?

We are changing medicine labels to make important information about your medicine easier to find. These changes are the result of many years of consultation - they bring Australian medicine labels up to date with international best practice.

Active ingredients will be easier to find

The active ingredient is the substance in the medicine that makes it work.
You probably know of paracetamol, ibuprofen or insulin - all of these substances are active ingredients. Under the new labelling rules active ingredients need to be more prominent. You will usually be able to find them below or next to the product name on the front of the medicine pack. Active ingredients will often be in a larger print size on the front label to make them easier to read.
Make sure to look for the active ingredients on your medicine labels so you know what you are taking.

Medicine information will be clearer

Most over the counter medicines will have critical health information in distinctive tables to help you use your medicine safely. Over the counter medicines are medicines that you buy without a prescription.
The new rules mean that critical health information will always be displayed in a consistent order and will be easy to recognise.
Always check the critical health information before you take your medicine.

More information on the label

Under the new rules more substances that could cause an allergic reaction will need to be included on labels. These substances include crustacea, fish, eggs, soya, milk and tree nuts.
For non-prescription medicines this information will be on the label. For prescription medicines this information must appear on the label or in the Consumer Medicine Information leaflet with a prompt on the pack.

More room for important information

The new rules include a minimum space for dispensing labels. These are the labels that pharmacists stick on prescription medicines with information from your doctor.
This space makes it easier for the pharmacist to attach the dispensing label without covering up other important information.

Why are medicine labels changing?

Labelling requirements for Australian medicines are being updated after many years of consultation with industry, health professionals and the community. The changes help bring Australian medicine labels up to date and align them with international best practice. They will help Australians to make more informed choices about their medicines and use them more safely.

When are labels changing?

The new labelling rules took effect from 31 August 2016. There is a four year transition period to allow medicine manufacturers time to update their labels and to sell their existing stock. This means that after 31 August 2016 you may start seeing updated medicine labels, but you could still see older labels as well. During the transition period both versions are acceptable - manufacturers need to meet either the old or the new rules.

From 1 September 2020 all medicine labels will need to meet the new rules.

What other information is on my label?

Labels have all sorts of useful information on them. Next time you look at a medicine keep an eye out for:

AUST R and AUST L numbers

Medicines sold in Australia will have either an AUST R or an AUST L number (but not both).

AUST R numbers

AUST R medicines (also known as registered medicines) are assessed for quality, safety and effectiveness before they can be sold. They include all prescription-only medicines and many over-the-counter medicines.

An AUST R number means the medicine is more tightly controlled and regulated.

AUST L numbers

AUST L medicines (also known as listed medicines) are lower risk self-medication products. They are used for minor health problems and are less regulated than AUST R.

Listed medicines include fish oils, multivitamins and herbal and homoeopathic products.

 

Storage conditions

Labels have to tell you how to store a product - some medicines lose their effectiveness if not stored correctly.

Expiry date

This is similar to the use-by date on food. Medicines should never be used after their use-by date - they can lose their effectiveness or even become unsafe.

Batch number and company address

The batch number and name and address of the supplier can be used to trace a medicine if a problem is found.

 

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What is your risk in increasing endotoxin levels due to the different sanitization methods? FAQ @ USP

1. Endotoxin levels are typically a concern only for WFI systems. Most WFI systems are sanitized by elevated temperatures (hot water is better than steam since no special engineering is needed for hot water sanitization and it is plenty adequate), though more may employ ozone in the coming years as ambient non-distillation purification technologies become more widespread with EP’s relaxation of the methods of preparing WFI in their WFI monograph. Since thermal or ozone sanitization of WFI systems is typically no less frequent than weekly, that is not enough time for biofilm (with its endotoxin) to develop in the system and be released by periodic sanitization.  If the systems are much less frequently sanitised, there is a chance that developing biofilm could release detectable endotoxin when killed by periodic sanitization.
2. If chemical sanitizers other than ozone are used (this would be very atypical for a WFI system or an endotoxin-controlled Purified Water system), the sanitizer would have to be rinsed out, which would also rinse out any released endotoxin.

Source: USP

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India's NRA for medicines is lauded by WHO

J P Nadda, Union Minister for Health & Family Welfare

In a letter to J P Nadda, Union Minister for Health & Family Welfare, the WHO applauded the country's NRA, declaring it "functional' with a maturity level of 4 -- the highest level as per currently evolved definitions in respect of 5 functions -- and maturity level 3 in respect of 4 functions. While, maturity level 4 indicates good results and sustained improvement trends, maturity level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.

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Global health leaders meet in Sri Lanka to discuss and reset the agenda on Migrant Health & World Health Organization (WHO)

Feb 22, Colombo: Global health leaders meet in Colombo, Sri Lanka, this week to discuss the migrant health and reset the agenda on migrant health based on the current trends of global migration.

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Aurobindo Pharma to set up vaccine manufacturing facility

The company has formed a joint venture (JV) with the Hyderabad-based Tergene Biotech Private Limited, a vaccine development company, for developing pneumococcal conjugate vaccine.

Drug maker Aurobindo Pharma will set up a facility to manufacture 50 million dosages of vaccines per annum as it plans to launch its vaccine products commercially in 2018. Vaccines segment is another addition to the company’s differentiated portfolio where there are unmet needs and limited competition, Aurobindo Pharma said in its annual report. The company has formed a joint venture (JV) with the Hyderabad-based Tergene Biotech Private Limited, a vaccine development company, for developing pneumococcal conjugate vaccine (PCV). Tergene is currently working on development of the PCV.

PCV is a commercially available vaccine with limited competition and a global branded market of more than USD 6 billion, it said. “Aurobindo will hold a majority stake in the JV (with Targene Biotech) and will fund the product development in a phased manner spanning over three years. Development work for a few more products has commenced towards building a sizable vaccines portfolio. Toxicology studies have been completed.

“A cGMP pilot plant for clinical lot manufacture is ready and we are now working on clinical trial protocols. The plans are to create infrastructure for 50 million dosage per annum, with the first phase launch being targeted for 25 million doses. All these efforts are being synchronised to achieve commercial launch of Aurobindo’s branded products in 2018,” the company said in its annual report.

It, however, did not disclose information related to location of the manufacturing facility. The company is also in the process of developing a wide range of oncology and hormonal products which would include vials (wet vials and dry vials), prefilled syringes, capsules and tablets that are used in the hospital as well as in oncology and renal clinics, the report said.

“A new R&D centre dedicated for generic research in the field of oncology and hormones has been set up at Hyderabad to develop anticancer drugs and hormonal products, both for solid and parenteral dosage forms. The oral, solid dose formulations sections of oncology and hormone manufacturing facility has been completed and commissioned.

“The injectable areas of oncology facility are expected to be commissioned in later part of 2016. We have selected over 50 oncology products in our portfolio and plans are to initiate the exhibit batches for more than 15 products in 2016-17 and the dossier filing in regulated markets are expected to be initiated in early 2017,” Aurobindo said.

The drug maker also said a new block to manufacture oncology API is being added keeping the future requirements, and the facility is expected to be operational in 2017-18.

Shared under: Pharma News

Source: Indianexpress

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What is the ICMRA?

The ICMRA is a venue for heads of national regulatory authorities around the world to enable a shared strategic leadership to address current and emerging global regulatory challenges and to better leverage resources in ways that expand global regulatory reach.

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India’s measles-rubella vaccination campaign a big step towards reducing childhood mortality, addressing birth defects

WHO NEWS

By Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia

World Health Organization congratulates India for launching one of the world’s largest vaccination campaign against measles, a major childhood killer disease, and congenital rubella syndrome (CRS), responsible for irreversible birth defects.

The campaign launched today to vaccinate more than 35 million children in the age group of nine months to 15 years with MR (measles and rubella) vaccine, once again demonstrates India’s commitment to improve health and well-being of its people by protecting children against vaccine preventable diseases.

The first phase of the campaign is significant as it is expected to accelerate the country’s efforts to eliminate measles which affects an estimated 2.5 million children every year, killing nearly 49 000 of them. The campaign also marks the introduction of rubella vaccine in India’s childhood immunization programme to address CRS which causes birth defects such as irreversible deafness and blindness in nearly 40 000 children every year.

India has made important efforts and gains against measles in recent years. Measles deaths have declined by 51% from an estimated 100 000 in the year 2000 to 49 000 in 2015. This has been possible by significantly increasing the reach of the first dose of measles vaccine, given at the age of nine months under routine immunization programme, from 56% in 2000 to 87% in 2015. In 2010 India introduced the second dose of measles-containing vaccine in routine immunization programme to close the immunity gap and accelerate measles elimination. Nearly 118 million children aged nine months to 10 years were vaccinated during mass measles vaccination campaigns between 2010 and 2013 in select states of India.

Today’s campaign, the first in the series to cover a total of 410 million children across the country over the next 2 years, is a truly remarkable, world-beating effort. Apart from improving the life-chances of millions of children in India, the campaign is expected to have a substantial effect on global measles mortality and rubella control target as India accounts for 37% of global measles deaths.

For the MR campaign to be effective, it is important that throughout its duration, and in routine immunization thereafter, no child is left behind.

Simultaneously, India continues to further strengthen surveillance for measles and rubella, an important learning from India’s polio eradication programme that helped to identify infected and vulnerable areas and populations and enabled the programme adopt appropriate strategies to eradicate the disease.

India has already beaten smallpox, polio, maternal and neonatal tetanus and, very recently, yaws. Further gains in the battle against measles will help achieve a number of other public health priorities.

A regional flagship of WHO in South-East Asia, elimination of measles will contribute to achieving Sustainable Development Goal’s target 3.2 which, among others, aims to end preventable deaths of newborns and children under five years of age by 2030

Source: WHO
Published under: Health News

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What to Ask Your Doctor Before Taking Opioids Every patient should ask questions when getting a new prescription

What to Ask Your Doctor Before Taking Opioids

(Your prescription is for you. Your doctor considers many factors when prescribing opioids. What’s safe for you might lead to an overdose for someone else.)

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Newborn dies after antibiotic injection in India

India, New Delhi: A newborn died and at least four others were in critical condition at Lok Nayak Hospital after they were allegedly administered wrong concentration of antibiotics on Sunday.

Sources said all the babies, less than a-month-old, developed some breathing problem and started turning blue due to lack of oxygen soon after the injection was administered.

Dr J C Passey, Lok Nayak hospital's medical superintendent (MS), told TOI that the newborn who died had serious infection. "The infection led to the death and not adverse reaction. We have already conducted a preliminary inquiry into the matter and further investigation is being carried out by the nursing superintendent," Passey said.

The other four babies were shifted to the neonatal ICU after they were observed to have a breathing problem, within hours of the antibiotic being administered. Doctors said while one of them is still in ICU-on ventilator support-the other three have recovered well. Sources said that the Lok Nayak MS was called to the health department to brief about the incident.

According to Dr Sidharth Ramji, who heads the neonatology unit at the hospital, they have about 40 newborns in the nursery at any given time. Of this, some have serious infections for which antibiotics have to be administered, he added. The newborns who developed adverse reaction were injected with Amikacin, a high-end antibiotic for serious infection, is safe to use, the doctor clarified.

"All the five babies were admitted to the newborn nursery and were being administered same antibiotics through injections for the past five-six days. It is possible that there was some mistake in mixing the drug, available in powder form, with saline water, leading to the adverse reaction," Ramji said.

He said all other newborns in the nursery were doing fine. "A team of neonatologists is constantly monitoring their vitals," said one of them.

Experts say India has a very high number of neonatal deaths in the world. According to government data, the number of neonatal deaths-children dying within the first 29 days of life-in the capital was 3,455 deaths in 2003 and it increased to 5,687 in 2013. The number of infant deaths (children who die before turning a-year-old) in the capital has also gone up over the past decade despite technological advancement. "There is an urgent need to maintain institutions where deliveries take place and equip them with adequate manpower to reduce mortality," said a doctor.

Published under News. 

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The Top 5 Reasons Companies Ignore Root Cause Analysis by Christian Green at gmpviolations

Anyone who works in manufacturing understands the importance of effective root cause analysis (RCA), but very few organizations invest appropriately in this skillset. There are a number of reasons, or rather excuses that we can identify that contribute to this situation

There always seems to be time to do the same job over and over

again, but no time to make sure it is done right the first time.

1.      “We just don’t have the time for RCA”

This is a common excuse in the manufacturing environment where fire fighting has become the normal way of doing things. Specialists spend their time running from one incident to the next, applying quick fixes to remove the symptoms before rushing on to the next problem.

In this environment, chances are that every member of the team is spending a good portion of the day addressing issues that could be eliminated if an underlying chronic condition within the infrastructure were resolved. There always seems to be time to do the same job over and over again, but no time to make sure it is done right the first time by eliminating the actual cause of the problem.

Statistics for repeat incidents build a compelling case for the time and cost savings of a good RCA capability within an organisation.

2.      The “Blame Culture”

It is inevitable that root cause analysis will uncover problems in your infrastructure that are the direct result of something incorrectly done—or not done—in the first instance. When there is a culture of finger pointing and blaming others, people may be reluctant to be involved in root cause analysis efforts for fear of being blamed for creating an error.

This can be avoided by concentrating on the process and not the people involved. It is also important to put ground rules in place to stop the process from turning into a witch-hunt. If people are concerned about being blamed, they are likely to withhold crucial information and slow down or even prevent the identification of the root cause.

3.      A Lack of Organizational Will

When complex problems are difficult to resolve, management commitment and support is required. This involves access to information, freeing up of resources, and having an open mind to solutions. Without management support for tackling big issues, the teams involved in root cause analysis will be pulled in other directions, are likely to become frustrated, and will, in all likelihood, not commit to the task of finding cause. Management must take the lead and assure team members of that they are committed to finding true cause.

4.      Lack of Skills, Knowledge and Experience in RCA

Effective root cause analysis requires a set of skills that may be lacking in the organization. Without a specific RCA skillset, a specialized team will struggle to find the root cause. It is likely to take longer, cost more, and be far less efficient than it would be if the appropriate training had been provided. Training and coaching in learning and applying RCA techniques removes this barrier and ensures that time spent in problem solving is effective and provides the results that are needed.

5.      Lack of Detail and Missing Data

When an organization is in fire-fighting mode, the information collected is often hurried and incomplete. It may be missing key facts that will aid in RCA. All too often, incident and problem data that is collected lacks the depth of information needed for a thorough assessment of the situation. When support teams jump to solutions without systematically collecting and analyzing the data, and if the selected solution eases the situation, little additional information will be collected. This leaves the problem-solving teams starting from scratch to investigate problems when many of the original details have been forgotten and never recorded. This makes RCA much more involved and difficult, bringing you back to the first point of not having enough time! It is a “chicken and egg” situation. Standardized collection of information by support staff will improve the success rate of your RCA initiatives.

An initial investment in training teams to use RCA, integrating the use of RCA processes, and removing some of the barriers to using RCA that are likely to exist in the organization, can pay big dividends in the long term. There will be some short-term pain in transitioning to effective root cause analysis as an integral part of an organization’s capability. However, the value of RCA will become evident as problems are efficiently and permanently resolved, and RCA becomes an integral part of operational activities.

Author: Christian Green

Critical Thinking Facilitator leading clients across industries to complex issue resolution:


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Change to IDA from CDSCO will usher in fresh wave of accountability & professionalism: Dr Jagashetty

The Drug Technical Advisory Board (DTAB)'s move to approve change of name of the ‘Central Drugs Standards Control Organisation (CDSCO)’ to ‘Indian Drug Administration (IDA)’ will now mandate a dedicated pool of qualified workforce to man regulatory system. This will take India on a global platform like that of US FDA and EMA, said Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO.

Following the 75th meeting of DTAB held on January 3, 2017, the Board’s approval to rename ‘CDSCO’ as ‘IDA’ to make it simple and befitting to its activities is the best that could happen to India’s regulatory office, he added.

During 2014, it was Dr Jagashetty in his role as the National Advisor who pressed for the CDSCO to be transformed with a name change to IDA and be given a different identity for an immediate recognition as an Indian Regulatory Authority across the globe. “Now the IDA will lay the foundation for qualified pharmacy professionals and this will automatically spur rapid license approvals in a transparent and efficient manner,” he said.

Once the name change is approved then the Government of India may direct all states to incorporate similar names in their states for administration of drugs like respective State DA (Drug Administration) or Respective State FDA (Food & Drug Administration) to bring in uniformity throughout country.

At the same time the Government of India should also introduce the Indian Drug Services (IDS) examination through UPSC for candidates to lead the IDA. This examination needs to be designed on par with the Indian Administrative Service (IAS), Indian Police Service (IPS) and Indian Foreign Service (IFS).

This IDS cadre may be known as Drugs Control Officers instead of Inspectors. They could be selected through UPSC and posted to various State DA or State FDA like that of IAS/IPS/IFS cadre. As and when required their services could be obtained or on deputation to IDA or other departments of health & family welfare, Ayush, food, veterinary, forest, chemicals, fertilizers, agriculture, industry, revenue, patents etc depending on the need. The position would exercise focused drug administration including framing and implementation of policy in consultation with the related ministries. Further, such a system would create a proper hierarchy and bring in a systematic reporting structure which is uniform to both Centre and State, Dr Jagashetty had said in an earlier interaction with Pharmabiz.

Dr Jagashetty, who was also the erstwhile chairman of the DCC sub-committee for Amendments to Drugs & Cosmetic Rules constituted by DCGI, feels that the Indian drug regulatory authority which scrutinizes the worlds’ third largest manufacturing base of pharma products by volume and 14th in value terms needs to have a more powerful image internationally.

In an era where patent expiry opens up opportunities for IDA personnel to approve not only branded biologicals but biosimilar and generic formulations, apart from new drug delivery devices like skin patches and inhalers. This is an age of innovation where information technology reigns and therefore online issue of licenses for sales and manufacturing and instant information of pharma companies will need in-depth skill training.

“It is high time that CDSCO aligns itself to its change of name to IDA to be more appropriate in the current context of developments of Digital India, Make in India, Uniform Code Pharmaceutical Marketing Practices (UCPMP), medical devices policy, price monitoring cells,” said Dr. Jagashetty.

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Update: FDA revises final guidances on interim policy for certain bulk drug substances used in compounding

FDA on 1/13/17, in response to stakeholder feedback, issued revised versions of two final guidance documents regarding the use of bulk drug substances in compounding.

The agency clarified that the policies described in the guidances do not apply to inactive ingredients. Inactive ingredients are not included in the definition of a “bulk drug substance” and, therefore, can be used in compounding without appearing on the bulk drug substances lists developed under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, if all applicable conditions are met.

The agency is also providing for regular updates to the categories of bulk drug substances described in the guidances. Previously, FDA stated that it would not evaluate new nominations for placement in one of the three categories until after it completed its review of substances already nominated with adequate supporting information.

The guidances now state that FDA will determine after submissions are received whether new nominations, including re-nominations of substances with additional supporting information, have sufficient information for FDA to review them. After making that determination, FDA will place nominated substances in the appropriate category on FDA’s website. FDA generally intends to update the categories with any new nominations the first business day of each month. This revised policy will further minimize unnecessary disruptions to patient treatment while FDA develops the lists of bulk drug substances for use in compounding.

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Donald Trump’s words spook Indian pharma stocks

Donald Trump’s words spook Indian pharma stocks 

MUMBAI: United States president-elect Donald Trump’s bashing of the pharmaceuticals industry has pushed shares of Indian drug makers down, as a possibility of pricing pressure in their most profitable market looms over these companies. 

In his first press conference after electoral victory, Trump on Wednesday vowed to force the US drug industry to produce at home and cut prices. 

“Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don’t make them here, to a large extent. 

And the other thing we have to do is create new bidding procedures for the drug industry because they’re getting away with murder,” he said. 

Trump will officially take charge as the 45th President of the United States on January 20. 

His comments impacted share prices of Indian drug companies on Thursday and the Bombay Stock Exchange healthcare index closed 0.73% down at 15,012.24, as top companies such as Dr Reddy’s, Sun PharmaBSE 1.14 % and LupinBSE 0.35 % have significant exposure to the US market. 

Shares of Reddy’s closed 2% down at Rs 3,011 on the BSE on Thursday, while Lupin fell 2% at Rs 1,489 and Sun Pharma lost 0.59% to close at Rs 644. 

In his address Trump said even though the US is the largest buyer of drugs in the world, the country does not bid properly. It will soon start bidding in a way that would help it save billions of dollars over a period of time, he said. 

As companies prepare for third quarter results, analysts are being conservative with their.. Expectations for the sector. Brokerage firm Jefferies said it expects another muted quarter for the pharma sector led by weakness in US business. The overhang of regulatory inspection by the US drug regulator and pricing in US will dominate the results as it expects 12% revenue growth for Indian pharma with a margin decline of 100 bps. 

Some global peers have indicated that pricing is likely to remain under pressure in 2017 also,” Jefferies wrote in its research note. Another worry that Indian drug companies have is the ongoing investigation by the US department of justice into suspected collusion by drug companies to artificially inflate prices. 

Donald Trump’s words spook Indian pharma stocks 

Source: economictimes

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