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US lawsuit puts generic drug imports from India under scanner

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US lawsuit puts generic drug imports from India under scanner
Washington, May 16 (IANS)
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A US class action lawsuit accusing India's Ranbaxy of large-scale deception on its generic drug applications puts a question mark on drug imports from India, the largest supplier of generic drugs to the US.
The problem of lack of compliance with US Food and Drug Administration (FDA) guidance and gaps in protocol make it difficult to buy generics from pharma companies in India, which supply at least 40 percent of all generics in the US, according to biopharmadive.com.

The latest class action lawsuit against Ranbaxy, recently purchased by Sun Pharma in a $3.2 billion deal, was filed by US retailer Meijer in district court in Massachusetts.
It seeks damages and monetary relief on behalf of all direct purchasers of drugs in cases where cheaper generics were not able to be introduced due to Ranbaxy securing the approvals under allegedly dubious premises.

The six-month period of exclusivity that comes with such approvals effectively shut other companies out of the market.

In 2013, Ranbaxy faced civil and criminal fines of $500 million in a settlement with the US related to claims that it sold substandard drugs and also made false statements to the FDA about its adherence to quality-control standards at its manufacturing plants, biopharmadive recalled.

In addition, Ranbaxy has been subjected to wider scrutiny and oversight from the FDA, which has resulted in a US import ban on all Ranbaxy drugs.
Also, in November 2014, the FDA stripped Ranbaxy of a tentative approval of generic Valcyte, dating back to 2008, it said.
 
We used to get Ranbaxy in UAE but it's decreasing gradually. A lot of buyers are reluctant to buy drugs from an Indian source for their lack of (perceived or not) effectiveness.

With that said, the FDA itself is a joke. There are loads of dubious goods in the US that have FDA approval.
 
We used to get Ranbaxy in UAE but it's decreasing gradually. A lot of buyers are reluctant to buy drugs from an Indian source for their lack of (perceived or not) effectiveness.

With that said, the FDA itself is a joke. There are loads of dubious goods in the US that have FDA approval.

Generic drugs marketed without brand names are generally less expensive than brand-name drugs, even though they are chemically identical to brand-name drugs and meet the same standards of the FDA (US Food and Drug Administration) for safety, purity and effectiveness.


The problem of lack of compliance with US Food and Drug Administration (FDA) guidance and gaps in protocol make it difficult to buy generics from pharma companies in India, which supply at least 40 percent of all generics in the US, according to biopharmadive.com.

So seems US FDA will make the protocols more easier and fill in the gaps so that cheaper medicine can be accessed by US citizens.
 
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India ranks fourth in pharmaceutical production in the world with a production output of about $31 billion in 2014.
Pharmaceuticals: 'Generics to double in five years’ - The Hindu
India ranks fourth in pharmaceutical production in the world with a production output of about $31 billion in 2014.
The domestic generic drug market is expected to cross $27.9 billion from the current level of $13.1 billion registering compound annual growth rate (CAGR) of about 16.3 per cent particularly due to approval accorded by USFDA makers and 21 drugs patent losing patent by 2019, according to a joint study by the Associated Chambers of Commerce and Industry of India (Assocham) and RNCOS.

Generics would account for 85 per cent share in the domestic pharma market by 2020, fuelled by cheap labour, patent cliff of blockbuster drugs and prevalence of lifestyle diseases, according to a study on ‘Generic Medicines in India - Promulgating Growth & Access.’

Generic drugs account for 75 per cent of the domestic pharmaceutical market by value. Drugs for cholesterol control, pain management, anti-coagulant, respiratory, liver disorders, depression and lipid regulators are highly prevalent in the global market.

Recently, Sun Pharma got the USFDA nod to manufacture generic hydocodone bitartate with acetaminophen (APAP) tablets. It is a narcotic analgesic indicated in the treatment of relief of moderate to moderately severe pain of acute, chronic, or post-operative types, adds the study.

However, the study pointed out that, the influence of physicians in India in terms of prescribing branded medicines and the lack of drug pricing control laws have limited the consumption of unbranded generics in the domestic market. Thus, Generics majors such as Sun Pharma, Lupin, Dr, Reddy’s and others have been targeting international markets for their revenue.

With key initiatives announced by Modi Government to include price control policies and the revision of Jan Aushadhi campaign, the market is likely to show a notable incline in the penetration of unbranded drugs, said D.S. Rawat, Secretary General, Assocham said.

The domestic pharma market was valued at $15.4 billion in 2014 and is expected to expand at a CAGR of 13.3 per cent to $32.7 billion by 2020. Driven by favourable demographics including growing aging population, increasing lifestyle diseases, steep growth in disposable incomes, and increasing penetration of Indian drug players in the global market, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size, the study observed.

The major export markets for the country’s pharmaceutical products are Americas, Europe, China, Japan, Africa, and others. The U.S. is single largest export destination. It accounts for nearly 28 per cent of Indian pharmaceutical exports, followed by the European Union (18 per cent) and Africa (17 per cent).

The pharma exports to the U.S. market are high due to the large number of approvals from the USFDA.

India has been the third-largest exporter of drugs to the U.S. market by volume and it has 370 FDA-approved manufacturing facilities outside the U.S., which is the second largest in the world.

India ranks fourth in pharmaceutical production in the world with a production output of about $31 billion in 2014. It has a 1.4 per cent share by value and 10 per cent by volume in the global pharma industry. India, one of the leaders in pharmaceutical exports, exports drugs worldwide to more than 200 countries.
 
Ministry of Chemicals and Fertilizers
05-November, 2015 12:34 IST

17 MoUs for Academia –Industry Linkages signed between NIPERs and Pharma Industry; Pharma initiative to build Innovation Ecosystem in India

One of the critical factors in building innovation ecosystem and for Drug Discovery is Academia-Industry linkage. Department of Pharmaceuticals for the last one year has actively engaged both the NIPERs and the Pharma Industry to build partnership in areas of education, research and development. The result is that 7 National Institutes for Pharmaceutical Education and Research (NIPERs) have undertaken Academia-Industry linkage with 17 Pharma Industries of Private and Public sector. These 7 NIPERs exchanged MOUs with Industry heads in the presence of H.E.President of India Pranab Mukherjee on 4th November 2015 as a part of Visitors conference being held now 4-6th November 2015. During the event, a total of 45 MOUs were exchanged between Central Institutions viz., IITs, NIPERs, IISERs,IIITs, IISc-B, NIFT, NITs, RGIPT, RGNIYD& SPAs. Of the 45, 17 are under Pharmaceuticals sector. Thus the initiative of Department of Pharmaceuticals stands out.

India enjoys global leadership in Pharmaceutical sector in Generic medicines. Department of Pharmaceuticals celebrates the achievements of both Public and Private Pharma Industry for their contribution in India’s self-reliance on medicines. Globally India ranks 3rd largest in volume and 10th in value. Every third tablet consumed globally is made in India. Exports are being made to more than 200 Countries with a major share in regulated markets. Much of the credit goes to policy initiative in terms of Patent Act, 1970 which allowed process patents, enabling in transforming India from medicine importing country to exporting country and Private and Public skill and entrepreneurship of Pharma Industry.


Pharma sector is a knowledge intensive science and technology based industry. Indian domestic pharma market is around Rs.1.00 lakh crores and its analysis suggests that patent medicines constitute less than 1% share illustrating poor accessibility/ availability of latest innovative medicines in the face of growing non-communicable diseases like cancer because of affordability. This issue reiterates the urgency for India to have paradigm shift in its strategy to expand its leadership in Drug Discovery and Innovation after post-WTO, TRIPS regime.India’s leadership in Drugs Discovery will not only make medicines affordable and will surely pave a way for India becoming a prosperous nation addressing the poverty as well. High risk and High investment are the hallmarks of drugs discovery.

High quality manpower is one of the critical requirements for its success. It is under these circumstances that the Government of India has set up NIPERs for nurture and produce high quality manpower for making India a global leader in Drugs Discovery. NIPERs are Institutions of National importance set up under NIPER Act, 1998 on the lines of IITs. Presently there are 7 NIPERs functional at Mohali, Ahmedabad, Guwahati, Hajipur, Hyderabad, Kolkata and Raebareli. One more NIPER at Madurai is in process of setting up. During 2015-16 2 new NIPERs were announced for Chattisgarh, Maharashtra and Rajasthan state.

Further in India, the research and development in Pharmaceuticals sector is spread across a number of Ministries and Departments viz., Department of Bio-Technology, Dept.of Science and Technology, Department Scientific and Industrial Research, Health Systems Research (ICMR) and Dept.of Pharmaceuticals. It is under these circumstances that the Department of Pharmaceuticals is drawing up a common road map for Drug Discovery through convergence and synergy involving all stakeholders.

Department of Pharmaceuticals has identified that Academia-Industry linkage as a basic requirement for translating research into development (commercialization) and Innovation; and also to fix accountability among the Educational Institutions. The initiative will be a historic event in the annals of Department of Pharmaceuticals in its endeavour of making India a global leader in Drugs Discovery.
 
Dr. Reddy’s shares decline after USFDA warning - The Hindu
Updated: November 6, 2015 13:12 IST
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Pharmaceutical major Dr.Reddy’s Laboratories (DRL) acknowledged on Friday that it has received a warning letter issued by the U.S. Food and Drug Administration (USFDA) dated November 5, 2015 relating to its active pharmaceutical ingredients (API) manufacturing facilities at Srikakulam in Andhra Pradesh (AP) and Miryalaguda in Telangana, as well as Oncology formulation manufacturing facility at Duvvada near Visakhapatnam in A.P.

This action follows the earlier inspections of these sites by the USFDA in November 2014, January 2015 and February 2015 respectively, the DRL stated in a press release.

Following this, the company's share price on BSE declined by Rs.565.60 (13.3 per cent) to Rs.3687 from the previous close of Rs. 4252.60.

The DRL Chief Executive officer G.V. Prasad said that the company would “respond with a comprehensive plan to address these observations within the stipulated time-frame of 15 days.”

“We take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards across all of our facilities. We will continue to actively engage with the agency to resolve these issues and we have also embarked on an initiative to revamp our quality systems and processes, as an organization-wide priority”, Mr. Prasad added.
 
Dr. Reddy’s gets anti-coagulant drug IPR rights for $17.5 million - The Hindu

Dr. Reddy’s Laboratories has completed purchase of worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug from Australian partner, Alchemia Ltd.

Announcing this, a statement from Dr. Reddy’s on Wednesday said the company had in September signed a term sheet for the transaction.

The completion follows Alchemia’s shareholders approving sale of Fondaparinux at the company’s AGM on November 10 after which the two companies executed a purchase and sale agreement, together with various patent assignment deeds.

Alchemia has received $17.5 million from Dr. Reddy’s as consideration for the sale and the agreement is effective July 2015. Fondaparinux is a generic version of the anticoagulant drug Arixtra, which is used in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). It is also indicated for the prevention of DVT after major surgery, such as knee and hip replacement.
 
Ministry of Chemicals and Fertilizers
21-July, 2017 17:59 IST
Demand notices of Rs. 74.65 crore issued to pharmaceutical companies for launching drug formulations without prior price approval of NPPA: Shri Mansukh Lal Mandaviya

Government effectively monitoring prices of scheduled medicines and taking action against companies found overcharging the consumers

Union Minister of State for Road Transport and Highways, Shipping and Chemicals & Fertilizers, Shri Mansukh Lal Mandaviya, in a written reply to a question in Rajya Sabha today, informed that during the monitoring of compliance of various provisions of Drugs (Prices Control) Order, 2013 (DPCO, 2013) by drug manufacturers, it is seen that the provisions related to ‘new drugs’ have not been followed in some cases wherein pharmaceutical companies have launched the formulation without taking prior price approval from National Pharmaceutical Pricing Authority (NPPA).

Shri Mandaviya informed that the concerned companies were instructed to furnish certified batch wise production and sales details along with the corresponding MRP for the formulations from the date of launch of the product till date. Demand notices for an amount of Rs. 74.65 crore have been issued to the erring pharmaceutical companies for launching such drugs / medicines without prior price approval of NPPA. Out of this, an amount of Rs. 1.05 crore has so far been recovered.

Further, the Minister said that the Government is effectively monitoring the prices of scheduled medicines and taking action against companies found overcharging the consumers based on the references received from the State Drugs Controllers / individuals, samples purchased from the open market and reports from market based data and complaints reported through the grievance redressal websites, ‘Pharma Jan Samadhan’ (PJS) and ‘Centralized Public Grievance Redress and Monitoring System (CPGRAMS)’.

****
 
Ministry of Chemicals and Fertilizers
25-July, 2017 15:26 IST
Rs. 238.84 crore recovered from Pharmaceutical Companies against non-compliance of provisions of DPCO, 2013: Shri Mansukh Lal Mandaviya

Minister of State for Road Transport and Highways, Shipping and Chemicals and Fertilizers, Shri Mansukh Lal Mandaviya, while giving a written reply to a question in Lok Sabha today, informed that, as on 30th June 2017, an amount of Rs. 238.84 crore has been recovered from the pharmaceutical companies against non-compliance of provisions of DPCO, 2013.

The Minister informed the House that whenever companies are found selling scheduled formulation at prices higher than the ceiling prices fixed by National Pharmaceutical Pricing Authority (NPPA), action is taken against such companies under the relevant provisions of Drugs (Prices Control) Order, 2013 (DPCO, 2013) and the overcharged amount, along with interest is levied on the company. Similar action is taken whenever companies are found selling non-scheduled formulation at a price which is 10% higher than the MRP of the preceding twelve months, Shri Mandaviya added.

During the monitoring of compliance of various provisions of DPCO, 2013 by drug manufacturers, it was seen that the provisions related to ‘new drugs’ have not been followed wherein some of the pharmaceutical companies have launched the formulation without taking prior price approval from NPPA. The concerned companies have been instructed to furnish certified batch wise production and sales details along with the corresponding MRP for the formulations from the date of launch of the product till date, Shri Mandaviya informed the House.

****
 
Ministry of Chemicals and Fertilizers
16-August, 2017 18:54 IST
Government fixes ceiling prices of Knee Implants; People of India to save Rs.1500 crore per annum

It is a step to prevent Unethical Profiteering and ensure Affordable and Quality Healthcare for the Last Man: Shri Ananthkumar

Overcharging of Knee Implants would be strictly monitored and penalized

“Walking the talk of Prime Minister, Shri Narendra Modi’s speech on Independence Day 2017, the Government has fixed the ceiling prices of orthopaedic implants used in knee surgeries from today”, informed Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananthkumar, while addressing the media here today. Based on the numbers of about 1 to 1.5 lakh orthopaedic knee procedures done in India every year, there will be a saving of about Rs.1500 crore for the people of India per annum. It is a step to prevent Unethical Profiteering and ensure Affordable and Quality Healthcare for the Last Man, the Minister added.


Shri Kumar said that as per the data analysis of National Pharmaceutical Pricing Authority (NPPA), under Ministry of Chemicals & Fertilizers, there was huge margin in trade which was found to be unreasonable and in a way unethical 'profiteering'. The NPPA, while fixing the ceiling prices, has kept all the new technology implants in mind and prices have been fixed accordingly, which are as follows:



Type of Knee Implant

Average MRP Earlier (Rupees)
Average Price Reduction
New Ceiling Price and MRP* (Rupees)


Cobalt Chromium (most widely used)
1,58,324
65%
54,720

Special Metal like Titanium & Oxidized Zirconium
2,49,251
69%
76,600

High Flexibility Implant
1,81,728
69%
56,490

Revision Implants
2,76,869
59%
1,13,950

Specialised Implants for Cancer & Tumour
Company specific prices; to be fixed by NPPA at Rs. 1,13,950

*Companies will print the MRP by adding GST on these ceiling prices


Shri Kumar informed that it is estimated by World Health Organization (WHO) that by 2020, osteoarthritis is going to be the fourth largest cause of immobility in the world. India has about 1.2 to 1.5 crore orthopaedic patients who require orthopaedic implant surgery. Most of the diagnosed people requiring knee surgery are not able to afford because of very high cost. Government is reforming this state of affairs putting a ceiling on knee implants from today, the Minister added.


Shri Kumar said that the Government expects full cooperation from all the stakeholders including importers, distributors, retailers, hospitals etc. in ensuring that the benefit of reduction of prices of knee implants reaches the last man. The Minister added that all complaints of overcharging would be strictly monitored and the overcharged amount would be recovered from erring parties with an interest of 18% over it. A step further, Shri Kumar added that the Government might also consider cancelling of licenses and initiate criminal proceedings against stakeholders engaged in unethical profiteering.


Other dignitaries present on the occasion were Minister of State for Road Transport & Highways, Shipping, Chemicals & Fertilizers, Shri Mansukh Lal Mandaviya, Shri Jai Priye Prakash, Secretary Pharmaceuticals and Shri Bhupendra Singh, Chairman NPPA.

************


Ministry of Chemicals and Fertilizers
16-August, 2017 15:10 IST
Department of Pharmaceuticals to observe Swachhta Pakhwada

Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, Government of India is observing Swachhata Pakhwada from 16-31st August, 2017.

Hon’ble Prime Minister, Shri Narendra Modi has underlined the need for all Ministries and Departments to take up their Swachhata Pakhwada much more seriously and on a substantial scale in order to make clean Indian a reality.

Action plan of Swachhata related activities prepared by the Department and circulated to all its organizations is being implemented. During the Swachhata Pakhwada, fortnight long cleanliness drives in the office/premises of the Department and autonomous institutes and public sector undertakings under its administrative control are being launched. The Department will carry out various activities relating to Swachhata such as weeding out of files, cleaning of office premises and Establishment etc.

Further, the Department has involved various Pharma and Medical Devices Associations and their manufactures, traders, retailers and chemists in the country to contribute positively towards this important initiatives of the Government. On 14.08.2017, Secretary (Pharma) took a meeting of the representatives of the Pharma Industries and advised them to (i) create awareness about the cleanliness among the employees and neighborhood areas, (ii) to adopt a defined area and maintain its cleanliness with involvement of the local authorities even after the Swachhata Pakhwada, (iii) to generate awareness for cleanliness drive through media at regional as well as at national level and (iv) to institute awards for Swachhata which would be given to manufactures/chemists etc. , at the Annual Pharma/ Medical Devices meet.

A mass pledge on the occasion has been administered by Secretary (Pharma) on 16.08.2017 in the Department and similar pledges were also administered in Pharma PSUs and NIPERs.



******


The Union Minister for Science & Technology, Earth Sciences and Environment, Forest & Climate Change, Dr. Harsh Vardhan witnessing the signing ceremony of an MoU between CSIR-Institute of Microbial Technology (CSIR-IMTECH) and Janssen Pharmaceuticals to pursue translational research in the domain of tuberculosis so as to address emerging challenges, in New Delhi on August 16, 2017. The DG, CSIR, Dr. Girish Sahni and other dignitaries are also seen.
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The Union Minister for Science & Technology, Earth Sciences and Environment, Forest & Climate Change, Dr. Harsh Vardhan addressing at the signing ceremony of an MoU between CSIR-Institute of Microbial Technology (CSIR-IMTECH) and Janssen Pharmaceuticals to pursue translational research in the domain of tuberculosis so as to address emerging challenges, in New Delhi on August 16, 2017. The DG, CSIR, Dr. Girish Sahni and other dignitaries are also seen.
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The Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananth Kumar addressing the press conference on fixing of ceiling prices of Knee Implants, in New Delhi on August 16, 2017. The Minister of State for Road Transport & Highways, Shipping and Chemicals & Fertilizers, Shri Mansukh L. Mandaviya is also seen.
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The Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananth Kumar addressing the press conference on fixing of ceiling prices of Knee Implants, in New Delhi on August 16, 2017. The Minister of State for Road Transport & Highways, Shipping and Chemicals & Fertilizers, Shri Mansukh L. Mandaviya, the Secretary, Department of Pharmaceuticals, Shri Jai Priye Prakash and the Principal Director General (M&C), Press Information Bureau, Shri A.P. Frank Noronha are also seen.
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The Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananth Kumar addressing the press conference on fixing of ceiling prices of Knee Implants, in New Delhi on August 16, 2017. The Minister of State for Road Transport & Highways, Shipping and Chemicals & Fertilizers, Shri Mansukh L. Mandaviya, the Secretary, Department of Pharmaceuticals, Shri Jai Priye Prakash and the Principal Director General (M&C), Press Information Bureau, Shri A.P. Frank Noronha are also seen.
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US doesn't like India making medicine accessible to poor people and not letting these greedy lunatics dominate the world.

Medicine should be to cure not to rule.
 
US doesn't like India making medicine accessible to poor people and not letting these greedy lunatics dominate the world.

Medicine should be to cure not to rule.


Pharma companies in India, which supply at least 40 percent of all generics in the US, according to biopharmadive.com.

Indian Establishment is well aware how the Indian Citizens are being treated aboard in EU Nations that they are even denying basic Health care for even legal immigrants and then talk about human rights of refugees.

The treatment of legal immigrants are way worst that even legal immigrants children are seen as not humans.

Tauta :disagree::disagree::disagree:

 
HYDERABAD, September 06, 2017 17:29 IST
Updated: September 06, 2017 17:32 IST
http://www.thehindu.com/business/In...drugs-in-us/article19630492.ece?homepage=true
drreddy


According to Dr.Reddy's, the Skelaxin brand and generic, as per IMS Health, had sales of approximately $139 million MAT in the U.S. during the twelve months ended July 2017. File | Photo Credit: P.V. Sivakumar


Pharma major Dr.Reddy’s Laboratories Ltd. on Wednesday announced the launch of the generic versions — an anti-depressant and muscle relaxant — in the U.S.

Bupropion Hydrochloride Extended-Release Tablets, the anti-depressant launched by the Hyderabad-headquartered firm, is a therapeutic equivalent of the generic version of GlaxoSmithKline's Wellbutrin XL tablets.

The Wellbutrin XL brand and generic had U.S. sales of around $754 million MAT for the 12 months ended July 2017, Dr.Reddy's said citing IMS Health figures.

The Bupropion Hydrochloride Extended-Release tablets, USP (XL), 150 mg and 300 mg, are available in bottle count sizes of 30, 90 and 500, a release from DRL said.

In a separate announcement, the company said it has launched Metaxalone tablets, a therapeutic equivalent generic version of Skelaxin (metaxalone) tablets.

A muscle relaxant, Skelaxin is z trademark of King Pharmaceuticals Research and Development Inc.

According to Dr.Reddy's, the Skelaxin brand and generic, as per IMS Health, had sales of approximately $139 million MAT in the U.S. during the twelve months ended July 2017.

The Metaxalone Tablets, USP 800 mg are available in the bottle count size of 100, a release from DRL said.
 
http://www.thehindu.com/business/In...ice-control/article19906273.ece?homepage=true
The government’s push for a change in the method of price calculation methodology for new drugs can lead to non-essential drugs coming under price control, a senior pharma industry body executive said.

Chemicals and Fertilisers ministry in a statement issued last week had said that the Department of Pharmaceuticals (DoP) is considering a change in the method of approving prices of new drugs.

“This proposal relates to doing away with retail price by ceiling price for ‘new drugs’. It has potential to bring non- essential drugs under price control, reduce competition and compromise growth,” Indian Pharmaceutical Alliance (IPA) Secretary General D G Shah told PTI.

The DoP should instead address the issue of delay in fixing the prices of ‘new drugs’ by the National Pharmaceutical Pricing Authority (NPPA), he added.

Earlier, the government had confirmed that it was considering a change in the method of approving prices for new drugs.

“The government is in consultation with the industry to explore doing away with the present practice of deciding a new price for each applicant of new drug, which is causing considerable time delay in launch of the new drugs in the market by the manufacturers,” the government release had said.

As per the Drugs (Prices Control) Order, 2013, a new drug is described as a formulation launched by an existing manufacturer of a drug of specified dosages and strengths as listed in the National List of Essential Medicines (NLEM) by combining the drug with another drug.

It also applies to a formulation launched by changing the strength or dosages or both of the same drug of specified dosages and strengths as listed in the NLEM.

Under the DPCO 2013, NPPA fixes ceiling price of essential medicines of Schedule I based on simple average of all medicines in a particular therapeutic segment with sales of more than 1 per cent of the category.

In respect of medicines not under price control, manufacturers are allowed to increase the maximum retail price by 10% annually.
 
Ministry of Corporate Affairs
01-November, 2017 14:04 IST
Competition Commission of India (CCI) imposes Penalty on All Kerala Chemist and Druggist Association and its District Units at Thrissur and Kasargod

The Competition Commission of India (‘Commission’) has found the All Kerala Chemist and Druggist Association (‘AKCDA’) and its District Units at Thrissur and Kasargod to be in contravention of the provisions of the Competition Act, 2002 (‘Act’). Four stockists (wholesalers) in the State of Kerala had alleged that AKCDA and its district level associations were insisting the requirement of a No Objection Certificate (NOC) prior to the appointment of any stockists, in contravention of the provisions of Section 3 of the Act, despite cease and desist orders of the Commission in earlier cases involving similar issues. It was contended that the practice of NOC simply changed from written approvals to verbal threats and was also being given in the form of congratulatory/appreciation letters to avoid any sanctions under the Act.


After getting the matter investigated by the Director General (‘DG’), the Commission has found that AKCDA and its District Units at Thrissur and Kasargod were indulging in the anti-competitive practice of insisting NOC prior to the appointment of new stockists by pharmaceutical companies. This case once again highlights the persistent attempts of anti-competitive conduct by Chemist & Druggist Associations who, despite various orders by the Commission in similar cases and wide publicity through a press notice issued by the Commission with respect to the NOC practice, have not abstained from indulging in such anti-competitive conduct. The Commission found that with a view to hide their apparent anti-competitive behaviour, these associations were insisting the NOC requirement through different nomenclatures.


Based on the evidence collected by the DG during investigation in this case, the Commission concluded that AKCDA and its District Units at Thrissur and Kasargod have been indulging in the practice of NOC prior to the appointment of stockists by pharmaceutical companies, which was limiting and controlling the supply of drugs in the State of Kerala, in violation of the provisions of Section 3(1) read with 3(3)(b) of the Act.


Further, the Commission has also found office bearers of AKCDA and its District Units at Thrissur and Kasargod, namely Shri A.N. Mohan Kurup (President, AKCDA), Shri Thomas Raju (General secretary, AKCDA), Shri O.M. Abdul Jaleel (Treasurer, AKCDA), Shri V. Anver (President, Thrissur District Unit, AKCDA), Shri Rajesh A.B. (Secretary, Thrissur District Unit, AKCDA) and Shri Venugopala S. (President, Kasargod District Unit, AKCDA), responsible under Section 48 of the Act, for their involvement in the anti-competitive practice.


Accordingly, AKCDA, its District Units at Thrissur and Kasargod, and their office bearers named above, have been directed to cease and desist from indulging in the practice of insisting NOC prior to stockist appointment. Further, the Commission imposed a monetary penalty of Rs. 4,78,545/-, calculated at the rate of 10 % of the average income of AKCDA, under the provisions of Section 27 of the Act. Penalties of Rs. 59,434/- and Rs. 53,889/-, calculated at the rate of 10% of their average income, were also imposed upon Thrissur and Kasargod District Unit of AKCDA, respectively. In addition, monetary penalties were imposed on the office bearers of AKCDA and its District units at Thrissur and Kasargod, at the rate of 10% of their respective incomes.


The detailed order can be seen at the Commission’s website www.cci.gov.in.


*****
 
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