Nirmal Gujarat Narrative: Myths and Realities

Can a sea-plane ride of a Prime Minister during the election campaign in his native state be enough indicative of development? The question demands an answer acceptable to all. Similarly, did Narendra Modi bring development in Gujarat for the first time? If so, then why the development model was missing from BJP’s election campaign in the politically crucial state of Gujarat? 

The hollowness of Gujarat Model, which was projected earlier as the ‘vision that India waits’ and the model which was mesmerizing people across India since 2014 Lok Sabha elections, has already been exposed by the experts and commentators. Its rhetoric may further be explained with one example – Nirmal Gujarat Campaign (NGC).

On December 30, 2007 Narendra Modi as the Chief Minister of Gujarat launched Nirmal Gujarat Campaign or the cleanliness campaign amidst much fanfare and pomposity and, the campaign was portrayed as one of the flagship projects of the state government as well as an integral part of the state’s development. On its decennium, therefore, NGC is brought under scanner as the state of Gujarat is facing its toughest electoral battle since last fifteen years.

It has been broadly campaigned that the concept of cleanliness was envisaged by Modi since his chief ministerial days and he has been the pioneer in his vision. However, the history reveals the truth quite contrary to such campaign. During the World Water Decade of 1980s, rural sanitation came into focus in India. The Central Rural Sanitation Programme (CRSP) was started in 1986 to provide sanitation facilities in rural areas. Subsequently, the government of India introduced the Total Sanitation Campaign (TSC) in 1999 to accelerate sanitation coverage throughout the country. It focused on public awareness campaign for sanitation facilities, particularly in schools. The main objective of the TSC was to improve upon the general quality of life in the rural areas through accelerated sanitation coverage. It is, therefore, evident that the utility of cleanliness was envisaged in India much before Modi became Gujarat’s Chief Minister. TSC was later renamed as Nirmal Bharat Abhiyan (NBA) on 1 April, 2012 by the then Prime Minister Manmohan Singh. After assuming power at the centre, Narendra Modi Cabinet just renamed NBA as Swachh Bharat Abhiyan on 24 September, 2014.

Now, let us understand as to how Gujarat was positioned among other Indian states on certain parameters of cleanliness when Modi became the chief minister in 2001. The Census of India published in the same year suggests that in terms of access to toilets, urban Gujarat was well placed among many Indian States. 76 per cent of the state’s urban population had access to toilets while it was 66 per cent in case of Andhra Pradesh, 53 per cent for Maharashtra and 72 per cent for Karnataka. The national average remained as 63 per cent. (See Table:1)

Table: 1

Access to Toilets in Indian States (% Urban Population), 2001

State	Access to toilets
	within premises
Andhra Pradesh	66.0
Gujarat	76.0
Karnataka	72.0
Maharashtra	53.0
Tamil Nadu	77.0
All India	63.0

Source: Census of India, 2001

However, the state could not retain its supremacy while considering the trends in access to toilets among urban households during the first seven years rule of Modi in Gujarat. Reports suggest that between 2002 to 2007-08, the average access to toilet facility among urban households in India was improved from 66 per cent to 76 per cent whereas in case of Gujarat it was from 79 per cent to 82 per cent only. (See Table:2)

Table: 2

Trends in Access to Toilets, Urban (% of Total Households)

State	Access to improved
	toilet facility
	(% of total households)
	2002		2007-08
Andhra Pradesh	77.0		82.1
Gujarat	79.2		82.4
Karnataka	67.8		59.3
Maharashtra	58.3		80.8
Tamil Nadu	62.4		67.5
All India	66.2		75.9

Source: Analysis based on District Level Household Survey (DLHS-2), 2002-04 and

            District Level Households and Facility Survey (DLHS-3), 2007-08

(Courtesy: Mehta; Meera and Dinesh)

Further, according to a study by the National Institute of Urban Affairs (NIUA)-2005, conducted in the year 2000 among 300 cities across 13 states in India, nearly 56 per cent urban population of Gujarat had access to sewerage facilities which was much higher than the national average of just 45 per cent. In case of Andhra Pradesh it was only 24 per cent and for Tamil Nadu around 48 per cent. (See Table:3)

Table: 3

Access to Sewerage Facilities in Indian States, 2000

State	Access to sewerage
	facilities
Andhra Pradesh	24.0
Gujarat	56.0
Karnataka	57.0
Maharashtra	64.0
Tamil Nadu	48.0
All India	45.0

Source: Computed from the National Institute of Urban Affairs (NIUA), 2005

            (Courtesy: Mehta; Meera and Dinesh)

In case of solid waste management (availability of garbage disposal arrangements in slums as well as non-slum areas) Gujarat was doing fairly well, according to a report published in 2002 (NSS Report 488: Housing Conditions in India, 2002: Housing Stock and Constructions). The lack of garbage disposal arrangements was just around 8 per cent for non-slum households in urban Gujarat, as against more than double national average of 19.2 per cent. Similarly, the proportion of slum households was also lower at about 22.7 per cent in Gujarat than the all India average of 26 per cent.

A project paper namely Performance Assessment System (PAS) Project on “Financing and Monitoring Urban Water Supply and Sanitation in Gujarat” published by the CEPT University, Ahmedabad in June, 2011. (by Meera Mehta; Dinesh Mehta and others) noted: “By 2001, about 91 per cent of urban population in Gujarat had access to piped water supply, exceeding the national average by almost 20 per cent, thus putting Gujarat among the first three states in India in terms of access to the service.”

Between 1981 and 1991, access to piped water in urban Gujarat had improved by about 18 per cent. By 2001, about 92 per cent of the state’s urban population had access to piped water supply. (See Table: 4)

Table: 4

Access to Piped Water Supply in Indian States (% of urban population), 2001

State	Access to improved
	water supply
Andhra Pradesh	78.0
Gujarat	92.0
Karnataka	89.0
Maharashtra	92.0
Tamil Nadu	83.0
All India	68.0

Source: Census of India, 2001

However, on analyzing the trend in access to the improved source of drinking water supply in the urban areas of different Indian states we may conclude that Gujarat under Narendra Modi during 2002-07 actually did not show much progress in terms of access to the improved source of drinking water supply. During the period, the conditions of Andhra Pradesh improved from 56.8 per cent to 98.2 per cent, Tamil Nadu from 40.5 per cent to 97.6 per cent and Karnataka from 58.1 per cent to 93.9 per cent. While the national average jumped from 56.7 per cent to 94.9 per cent; the state of Gujarat could reach only up to 97.8 per cent from a much healthy situation of earlier 80.1 per cent.  (See Table: 5)

Table: 5

Trends in Access to Improved Source of Drinking Water Supply, Urban

State	Access to improved source of
	drinking water supply
	(% of total households)
	2002		2007
Andhra Pradesh	56.8		98.2
Gujarat	80.1		97.8
Karnataka	58.1		93.9
Maharashtra	77.8		97.7
Tamil Nadu	40.5		97.6
All India	56.7		94.9

Source: Analysis based on District Level Household Survey (DLHS-2), 2002-04 and

District Level Household and Facility Survey (DLHS-3), 2007-08

(Courtesy: Mehta; Meera and Dinesh)

The above analysis shows that Gujarat was poised well in terms of cleanliness even before Narendra Modi sworn in as the state’s chief minister. However, Modi government in Gujarat celebrated the year 2005 as the ‘Urban Year’ as a part of “Vibrant Gujarat” programme focusing on ‘a comprehensive and holistic urban governance vision’. Though the attention on Urban Gujarat was strengthened with assistance from the Government of India’s (UPA-I) Jawaharlal Nehru National Urban Renewal Mission (JNNURM) programme under which four cities of the state namely Ahmedabad, Surat, Vadodara and Rajkot received funding from the centre. Thus, Narendra Modi’s startling on-camera celebration, claiming the success of Gujarat Model ‘only because of his good governance’, hides many facts and suppresses many truths.

Subsequently, what was the outcome of Nirmal Gujarat Campaign in terms of its impact on sanitation standards in slums, on eradicating open defecation and on the level of cleanliness in urban areas? A report namely “Nirmal Gujarat Rapid Impact Assessment”, published in June, 2009, highlights that more than 74 per cent of slum dwellers did not have immediate access to toilet because of their unavailability in the immediate areas around the slums; more than 41 per cent chose open defecation; just a little over 10 per cent in slums use toilets. Further, in absence of waste collection service, citizens disposed off their garbage on streets and such phenomenon was common within lower income groups. Generally, richer people were more satisfied with the campaign than the poor ones.

During 2010, three years after the launch of Nirmal Gujarat campaign, six areas of the state namely Ankleshwar, Vapi, Ahmedabad, Vatva, Bhavnagar and Junagadh were declared as the critically polluted by the Ministry of Environment and Forests (MoEF), Government of India, based on the Comprehensive Environment Pollution Index (CEPI). While CEPI scores of 70 and above were considered as critically polluted industrial clusters, Vapi was found to have a score of 88.09 in the year 2010. Gujarat Pollution Control Board (GPCB), in its report “Comprehensive Environmental Pollution Abatement Action Plan, Vapi Industrial Cluster– Gujarat” published from Gandhinagar during 2010 acknowledged the fact and assured the MoEF that it would implement its action plan to improve environment quality of the region. This action plan is known as the Vapi Action Plan.

Vapi Action Plan had various management and mitigation measures like safe disposal of industrial waste and treated water; strengthening air quality monitoring etc. The plan also recognized that the non-compliance by industries mainly caused environmental pollution in the region. Earlier in 1989, Vapi was declared as critically polluted. Therefore, in 2010, a moratorium was imposed on the expansion of industries and the setting up of new ones at Vapi. Despite its entire action plan, CEPI score in 2013 showed that Vapi still topped the pollution charts with a score of 85.31. Considering the impact on human health and very high level of exposure of humans to the pollution, MoEF re-imposed the ban on any permission to any new or expansion of project in Vapi.

Despite hazardous pollution issues, the plutocracy of Gujarat was continuously pushing to lift the moratorium. In 2016, Modi-government at the centre revised the CEPI to do away with the parameters like the impact on human health and environmental degradation. The new CEPI ensured that the areas like Vapi would no longer be classified as critically polluted and, hence, an inflow of industrial activities would be allowed. As a result, in November 2016 MoEF lifted the moratorium on expansions and new investments in three industrial clusters in Gujarat namely Ankleshwar; Vapi and Vatva. Thus, corporate profit was cared over environment’s safety and people’s health by the Modi government at the centre.

The failure of Nirmal Gujarat Campaign is just one among many claims of BJP’s development model. Hence, the reason for dumping the model, during election campaign in the state from where it was originated, is easily understandable. But, discussion on the subject should not end there since the tax payers’ money was involved in its large scale advertisement. Should one conclude that the Nirmal Gujarat was a failed campaign which only benefited Narendra Modi to build his image at the cost of state’s exchequer?

In 2002, out of 182 seats in Gujarat assembly, the BJP won 127 seats with a vote share of nearly 50 per cent. This fell to 117 seats and a vote share of 49.12 per cent in 2007 which was further reduced to 115 seats and 48.30 per cent vote share in 2012. After the first round of polling is over, the outcome of the election in 2017 is anybody’s guess. However, the ‘saga’ of Nirmal Gujarat Campaign is narrated – its myths and realities are expounded.

@pradipsinterpretations

  

 NDDS or Evergreening of Patents? 

The Draft Pharmaceutical Policy - 2017

(Article-5)

The Department of Pharmaceuticals (DoP) under the Ministry of Chemicals & Fertilizers recently released the 18 page Draft Pharmaceutical Policy – 2017 which has been circulated among various stake-holders of the pharmaceutical industry and civil society. 

In an attempt to understand the draft, I have decided to present a series of articles portraying my own interpretations on this draft policy. The fifth article is here.

Acceptance of Novel Drug Delivery Systems (NDDS) as “New Drug” violates the Laws of the Land

The Draft Pharmaceutical Policy – 2017 notes: “There is disproportionate focus on generic formulations to the point of exclusion of lack of adequate R&D. Whatever R&D is there is also limited to new processes for the same product (Novel Drug Delivery System – NDDS). For a long-long time there has been no molecule discovery by indigenous manufacturers.” [Para:3.4; Page:7 of the draft].

The above observation is biased and paradoxical. Focus on generic formulations for their adequate production by the indigenous manufacturers has actually helped the nation to attain self-sufficiency for the supply of medicines. How that could be the reason for lack of adequate R&D? Manufacturing of medicine in sufficient quantity cannot contravene the research and development work for invention of newer drugs. Rather, both should be concomitant. However, based on the above observation, the draft policy suggests, “All Novel Drug Delivery Systems should be considered as ‘new drugs’, unless certified otherwise by the licensing authority. This will also encourage innovations.” [Para:5.17; Page:15 of the draft].

Such “policy initiative” adopted by the government at the centre raises serious doubts about its intentions. World-wide the research pipeline for drugs and pharmaceuticals has become virtually dried up. The healthcare and pharmaceutical industry changed radically once the era of patent protection gradually started winding down. The patent cliff era began in earnest in 2011 and crescendoed in 2012. Some major well-known drugs—like Lipitor (atorvastatin), Plavix (clopidogrel), and Singulair (montelukast)—faced patent expirations and increased competition in the United States. According to estimates by Evaluate Pharma, a whopping $120 billion in sales was lost to patent expirations between 2009 and 2014. Evaluate Pharma also forecasts that $215 billion in sales will be at risk due to patent expirations between 2015 and 2020. [Source: Drug Patent Expirations: $190 Billion Is Up for Grabs; by VanEck]. This trend will pressure the sales and earnings of some of the major multinational drug firms. Under these circumstances, the multinationals are desperate to maintain their high profits by various ways and means. One such method is obviously the evergreening patent rights of their products under the WTO regime.

Fortunately, India could protect its interest against such multinational hegemony in drugs and pharmaceuticals through the Section 3(d) of the Indian Patent Act 1970 (as amended in 2005) which does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy.  According to the Section (3d), such invention or discovery is “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” [Source: indiakanoon.org]. Such legal provision defended the country’s interest in the court of law when multinational drug firms like Novartis and Bayer were challenged against over-pricing their anti-cancer drugs.

The Supreme Court of India rendered judgment on an appeal by Novartis against rejection by the India Patent Office of a product patent application for a specific compound, the beta crystalline form of imatinib mesylate. Imatinib mesylate is used to treat chronic myeloid leukemia and is marketed by Novartis as “Glivec” or “Gleevec”. Affirming the rejection, the Supreme Court confirmed that the beta crystalline form of imatinib mesylate failed the test of Section 3(d). The Court clarified that efficacy as contemplated under Section 3(d) is therapeutic efficacy. [Source: The Judgment In Novartis v. India: What The Supreme Court Of India Said; Intellectual Property Watch].

The US drug lobby never appreciated Section 3(D). Minister of State (Independent Charge) in the Ministry of Commerce & Industry Smt. Nirmala Sitharaman, in a written reply informed Rajya Sabha on 30 July, 2014 that “the Indian Patent Act does not allow evergreening of patents. This is a cause of concern to the US pharma companies.” [Source: Press Information Bureau, Government of India, Ministry of Commerce & Industry]. Therefore, it was necessary for the corporate serving government to dilute the very existence of Section 3(d) in the pharmaceutical scenario of India to please their masters particularly those who are in abroad. The acceptance of NDDS as “new drug” is a major step towards that. It is important to note that, “making small changes to a drug, often about to come off patent, in order to gain a new patent that extends its manufacturer's control over it is a way of cheating on the implicit bargain of patents: that a government-backed monopoly is granted in exchange for the invention entering the public domain at the end of the patent's lifetime.” [Source: Indian Supreme Court Rejects Trivial 'Evergreening' Of Pharma Patents; techdirt]

Now, for any existing drugs if NDDS is developed and the same is considered as “new drug”, patent protection would be extended in that case and that “new drug” will be kept outside the purview of price control. In this regard, the draft policy mentions: “DPCO will include only ‘off-patent’ medicines in its schedule. ‘In-Patent’ medicines will not be subjected to price ceiling by NPPA.” [Para:5.18 j ii; Page:17 of the draft] Therefore, such provisions in the draft policy, if finalized, would result in increasing medicine prices while ensuring the endless monopoly for few drug majors mostly the multinationals. During the post-patent regime, when the monopoly of multinationals is at stake, this would perhaps be the most priceless gift for them from the Modi-government!

(To be continued....)

@pradipsinterpretations

No Responsibility of Quality Control for Multinationals

The Draft Pharmaceutical Policy - 2017

(Article-4)

The Department of Pharmaceuticals (DoP) under the Ministry of Chemicals & Fertilizers recently released the 18 page Draft Pharmaceutical Policy – 2017 which has been circulated among various stake-holders of the pharmaceutical industry and civil society. 

In an attempt to understand the draft, I have decided to present a series of articles portraying my own interpretations on this draft policy. The fourth article is here.

Abolishing Loan Licensing would free multinationals

from their responsibility of quality control

The Draft Pharmaceutical Policy – 2017 has mentioned: “Loan licensing was decided to be discontinued in phased manner in the drug policy 1986” since “it raises many quality maintenance and assurance issues.” [Para:5.8; Page:12 of the draft]. The paragraph concludes by saying: “(i) phasing out over 3 years (ii) loan licensing to be allowed only for WHO GMP approved facility (iii) loan licensing to be allowed upto only 10% of the total production of the Company.” Such statement appears to be bold and deserves applause. The draft, despite waging war against loan licensing, cleverly maintained silence on contract manufacturing.

According to “Drug Quality and Safety Issues in India” published by the Indian Council for Research on International Economic Relations in September, 2015: “In India, at present, manufacturing of drugs is done in three ways–own licence, loan licence and third-party agreements. In case of a loan licence, any company which does not have its own arrangements for manufacturing can use the facilities of another manufacturer. In this scenario, the applicant of a loan licence often provides the necessary raw material to the manufacturer and maintains strict oversight during the entire process. Third-party agreements, on the other hand, just entitle a manufacturer to undertake the manufacturing process on behalf of another entity that would only market the product, with greater autonomy of operation to the former. During our field research, we found an absence of clarity among respondents on the legal liability with regard to quality of products that enter the market through third-party manufacturing.” [Maulik Chokshi; Rahul Mongia and Vasudha Wattal].  

The loan license is defined under Rule 69-A and 75-A of the Drugs & Cosmetics Rules 1945, whereas, there is no third party manufacturing agreement provision in the Act and Rules. [Source: Drug manufacturing can be outsourced from a loan licensee; 04 March, 2015]. Third-party or contract manufacturing is actually out sourcing of products which provides easy solution for manufacturing one’s own brand names from other manufacturing unit. It is a very popular concept among marketing companies. In third-party manufacturing, name and address of the manufacturer must be mentioned on the label of the drug. Marketing company’s name should be mentioned separately. Ownership of brands will be the property of the marketing company but quality will be the responsibility of the manufacturing company. According to Pharma Franchise Help, “Multinational companies are also gotten manufactured their products at loan license or third party basis.” [Source: What is third party/contract manufacturing in Pharmaceuticals/Ayurvedic sector? Procedure, Requirements, Inventory]. In absence of loan license, multinationals would manufacture their products on third party basis only. Thereby, they would enjoy the brand equity but for quality assurance some small company from remote parts of the country would be held responsible!

The article, “List of Contract Manufacturing Pharma Companies in India” by Pharma Tips, published on 2 February, 2013 noted: “In spite of all the assurances, given by the multinational, a lot of scepticism has crept in to the views on contract manufacturing. Most of production personnel deputed in these plants have always commented that they have been unable to exercise the same controls as they could have in their own parent company.” The article further stated: “Today most of the companies including the minor contract manufacturers have moved to the remote areas of Himachal Pradesh, Sikkim to gain certain tax benefits. The question is—do these units have the required infrastructure, facilities, work force availability as is present in the major cities such as Delhi and Bombay. Many of the blue chip companies have even got their products manufactured on contract from these companies based in these remote areas.” [Source: Pharma Tips].

The draft pharmaceutical policy, incidentally, wants to abolish drug manufacturing under loan license which does have certain legal provisions to ensure the quality of medicines. But, it does not target third party manufacturing which is outside the purview of law and does not guarantee the quality of drugs. Therefore, the question is whether quality of medicine is the priority or under its pretext multinationals are freed from all responsibilities.

(To be continued.....)

@pradipsinterpretations