GN Singh

CDSCO – “Investigator can do more than 3 clinical trials at a time”

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In a decision that will go a long way in boosting the clinical trial industry in the country, the Union health ministry has removed the restriction on the number of clinical trials an investigator can undertake at a time. At present, no investigator should conduct more than three trials at any given period of time. Removing the restriction, the ministry has now empowered the ethics committee to take a final call on the number of clinical trials an investigator can do at any given time after examining the risk and complexity involved in the trials.

Earlier, there were objections from the stakeholders including the clinical trial organisations in the country against the health ministry’s decision to restrict the number of clinical trials an investigator can do at a time as they felt that the restriction was impeding clinical research in the country as this has led to the under-utilisation of the healthcare infrastructure developed over the last one decade on one hand coupled with high attrition rates in the industry.

Experts were of the opinion that studies conducted for vaccines may require 10,000 trial subjects whereas studies on cancer may require 60 to 70 trial subjects. Therefore, restricting the number of studies for an investigator is not justified in the interest of clinical research. Institutional ethics committee should be given the power to govern the number of studies an investigator can undertake based on requirement of a particular study because in each therapeutic area the study requirement varies immensely.

In the light of widespread resentment against the restriction, the Union health ministry convened several meetings with the industry associations and other stakeholders. To deliberate stakeholders concerns and the way forward relating to some issues on conduct of clinical trials in India, two such meetings were held on 20.8.2015 and 6.10.2015 under the chairmanship of secretary, ministry of health in which other experts in the field were also present.

After detailed discussions and deliberations, the ministry decided to do away with the restriction. “As regards restriction that no investigator shall conduct more than three trials at any given period of time, it has been decided to remove this restriction and it is further decided that ethics committee after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can undertake”, Drugs Controller General of India (DCGI) Dr GN Singh, in his order said.

Source: 1, 2

Drugs and Cosmetics Act to be revamped by CDSCO soon.

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Central Drugs Standards Control Organisation (CDSCO) is working towards drafting a new Drugs & Cosmetics Act, 2016 and a Medical Devices Act, 2016. The move follows after the ministry of health and family welfare initiated steps to revisit the D&C Act 1940 and Rules 1945. The effort is to match up with the current regulatory requirements related to safety, efficacy and quality of drugs and medical devices.
The government  has taken a decision to remain updated to newer technology and with the onset of several revised guidelines that have come in not just from global regulatory authorities but also India. Moreover, for the government, pharmaceuticals is a priority sector and therefore it has found it critical to ensure that its regulations are required to be strengthened.
Going by the new developments spanning from online pharmacy, fixed dose combinations to medical devices manufacture needs revision the existing D&C Act & Rules and the effort to draft the D&C Act, 2016 and rules are being updated. In fact, a notice has been issued by director (Admin) of CDSCO on June 6 to all state drugs controllers requesting to give feedback based on their experience within 15 days from the said notice. There have been several transformations like new brands, biologicals and biotech drugs besides the fixed dose combinations that need a set of dedicated rules.
The US FDA audits reported data integrity which has resulted in a slew of warning letters and suspension orders on production for poor documentation. The Drugs and Cosmetics Act & Rules 2016 will also ensure complete compliance by the Indian pharma industry.
There is also the introduction of Central Licensing Authority (CLA) along with State Licensing Authority (SLA) and Central Licensing Approval Authority (CLAA) for Schedule III drugs in the last year’s Amendment Bill.
The new regulations may also cover the Uniform Code for Pharma Marketing, Formation of Task Force to formulate bulk drug policy, medical devices policy, creation of price monitoring and resource units in the state drugs control department.
With active pharmaceutical ingredients (APIs) being the core of any drug formulation, the government has seen the need to come out with a bulk drug policy and therefore the new Drugs and Cosmetics Act 2016 may see appropriate related inclusions.
In an age of information technology and with the advent of e-commerce, online pharmacy is the way forward. With several companies already in this line of business, the government has called for fresh set of guidelines to be imposed for this business model to keep violations at bay by forming a committee under the chairmanship of Maharashtra FDA Commissioner and yet it has to submit its recommendations in this regard.
With Prime Minister Narendra Modi’s slew of programmes like the Make in India and importance of indigenous manufacture of medical device is being promoted. This may call for dedicated chapter in the D&C Act, 2016 with rules for monitoring and manufacturing unless separate Act and rules are framed for regulation of medical devices.
For the pharmacy trade, penalty clauses are likely to be included. It would make certain that industry and trade will not be able to exploit and embark on unfair practices.

Source: 1

FDCs licenced prior to Sept 21, 1988 excluded from proving safety, efficacy to DCGI

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Thousands of FDC drug manufacturers in the country engaged in production of drugs licensed prior to September 21, 1988, can now heave a sigh of relief as the Drugs Controller General of India (DCGI) has excluded such drugs from the requirement of proving the safety and efficacy of FDC drugs licenced by the SLAs without due approval from the DCGI.

On January 15 last year, the DCGI had asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and had made it clear that those FDCs approved by the State licencing authorities (SLAs) from October without the permission of the DCGI will be considered for ban.

“An issue has been raised regarding applicability of above requirements for FDCs licensed by State licencing authorities before 21.09.1988, after which all relevant provisions relating to New Drugs were introduced in Drugs and Cosmetics Rules.  The matter has been considered by this office and it is hereby clarified that requirements of providing safety and efficacy as mentioned above is not applicable for such FDCs which are licensed prior to 21st September 1988”, DCGI Dr GN Singh clarified in a letter addressed to all the state drug controllers in the country.

The DCGI’s clarification comes at a time when the DCGI’s office is conducting the massive exercise of examining the rationality of thousands of FDCs permitted by the SLAs without due approval from the DCGI.

The union health ministry had earlier constituted expert panels for the exercise of examining and regularising the thousands of fixed dose combinations (FDCs) permitted for manufacture and sale in the country without due approval from the DCGI. The expert panels have already held three meetings and the fourth meeting is scheduled for June 11.

Source: PharmaBiz

India to double drug regulators; to set up testing labs at ports: Govt officials

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The Indian government will more than double the number of regulators in three years and set up state-of-the art testing labs at ports to ensure the pharmaceuticals and drugs exports shipments meet global quality standards while following a zero tolerance policy for any laxity, senior officials in the Union health and commerce ministries said.

Speaking on the sidelines of the three-day international exhibition for pharma and healthcare ‘iPHEX’, which began here on May 21,  Drugs Controller General of India (DCGI) Dr G N Singh said the central government will be spending over Rs.3,000 crore in the next three years (under the 12th Plan) towards enhancing the capacity of the regulators both at the centre and state levels.  While the number of regulators will increase to 1,000 from 500 at the central level, as many as 3,000 regulators will be deployed at the state levels. In India, the regulatory system works at the dual level – at the central and state levels.

“India’s reference system (for drugs testing and IP) will be at par with the top world standards in two-three years and will even match the US in three-five years,” Dr Singh said.

Joint secretary in the commerce ministry, Sudhanshu Pandey, said that the Union government is following a “zero tolerance” policy for ensuring that India not only maintains but further strengthens its ranking in the world pharmaceuticals market.  He said these measures on quality assurance are even more important when a big opportunity would be unfolding in the off-patent generics in the next few years as more than 160 drugs will go off-patent till 2018.  He also made it clear that the government stands behind zero tolerance when it comes to human lives.

India’s regulators including DCGI himself along with state level FDAs have all gathered in Mumbai at the ‘ iPHEX’, organised by the industry body Pharmaceuticals Export Promotion Council of India (Pharmaexcil) and are engaged in deliberations with regulators from 40 countries.

Chairman of the iPHEX organising committee Bhavin Mehta said the ‘iPHEX’ has become a much sought after event among the global buyers who are looking up to India as a dependable source of affordable drugs.

  Source: PharmaBiz

HSI India applauds DCGI’s decision to replace animal testing with modern non-animal alternatives

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Humane Society International (HSI) India expressed relief and hope over the Drugs Controller General of India (DCGI) decision to contemplate over possibilities of replacing drug testing on animals with alternative no animal testing methods. It is understood that the Central Drugs Control Organisation (CDSCO) is giving serious thought on modernising India’s pharmaceutical safety assessment by replacing old-fashioned animal testing with modern non-animal alternatives.

The association applauded and stressed that the visionary approach to science adopted by the DCGI is appreciable, as nine out of ten experimental drugs that appear safe or effective in animal tests go on to fail in human patients because there are simply too many biological and physiological differences between the species for these methods to be reliable. Thus we strongly believe that the approach taken by Dr G N Singh who is the DCGI of the country will contribute for the greater good of the patients and animals alike.

According to Alokparna Sengupta, research and toxicology campaign manager, HSI India, “Dr Singh is showing visionary leadership in his efforts to implement transformational change in India’s science infrastructure. Moving away from outdated and unethical animal tests and aligning India’s pharmaceutical regulations with those of other leading economies is a step forward for human health, industry and animals alike. HSI has successfully worked with governments and scientists across Europe, North America and beyond, and we look forward to working with Dr Singh’s office to advance 21st century safety science in India, too.”

It is understood that with an aim to curb the misuse and torture of animals used for animal testing the DCGIs office is working very hard with the Indian Pharmacopoeia Commission (IPC) to replace some of the existing monographs with the alternative modern methods which includes sophisticated tests using human cells and tissues known as ‘in vitro’ methods. While serious thought is also given to adopt advanced computer-modeling techniques referred to as in silico models, and studies with human volunteers.

Humane Society International India has been actively advocating non-animal test approach for many years and have been conducting series of workshops and conferences across India, presenting the expertise of international scientists in modern chemical and pharmaceutical toxicity testing. One of such test is the Tox21’ the transition to high-tech, human biology-based safety testing that was recently discussed at a science workshop in Hyderabad by HSI’s president Dr. Andrew Rowan.

Source: PharmaBiz