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As law enforcers tighten grip on pharma companies, patients suffer

Dr Dinesh Verma (name changed) took pride in being the first person from Punjab to have cleared the prestigious Diplomate National Board (DNB) Psychiatry in 2013.

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Dr Dinesh Verma (name changed) took pride in being the first person from Punjab to have cleared the prestigious Diplomate National Board (DNB) Psychiatry in 2013.

Passionate about his medical practice in psychiatry and substance-use disorders, he attended a huge number of patients per day, mostly drug addicts.

However,Verma's life changed one morning in December 2014, when on the way for a routine OPD visit to a city hospital, his car was stopped by two police vehicles. Next he knew was that cops had arrested him for carrying and supplying banned drugs.

"I remained in jail for close to 45 days and was eventually released on bail by an additional sessions judge, who in the bail orders raised serious questions on the NDPS Act being applicable on qualified psychiatrists," wrote Verma in the July edition of International Doctors for Healthier Drug Policies, a global network of doctors.

Verma suffered the fate of three others from his state, who were arrested on similar charges, as a consequence of their arrest, were sacked from the employing hospitals or lost their entire business from private practice.

Scared after their doctors' arrest, many of their patients discontinued the treatment midway, and a few others returned to drug addiction.

Experts claim that as the law enforcement agencies crack down on rising illicit drug use, stakeholders in the pharma industry are bearing the brunt.

While the pharma industry faces increased scrutiny from investigators, the patients are a suffering lot. Those with life-threatening diseases undergo huge pain and agony due to the shortage of palliatives, drug addicts on recovery path face the danger of returning to drug abuse while those down with as ordinary as cough bouts have to be content with less effective medication.

"The regulatory laws are notorious even as officials from scores of government agencies have concurrent powers to investigate. Ignorant about medical uses and legitimate entities which are licensed under the NDPS Act, they tend to paint everyone with the same brush," said Devesh Malladi, head of narcotic drugs and psychotropic substances (NDPS) committee at trade association body Indian Drug Manufacturers Association (IDMA).

"This has led the pharma industry to export most of its produce, leaving barely anything for local consumption. The losers are the patients who do not get access to these medicines easily and, therefore, suffer," said Dara Patel, general secretary, IDMA.

Further, in order to make up for the shortage, the pharma companies have started making its substitutes even though these are less effective, claim the pharma company executives.

Ephedrine and its derivative pseudoephedrine, well-known medicines for cough and cold treatment, are now giving way for other alternatives which are less effective.

A media executive whose pregnant wife was recently prescribed a codeine-based cough syrup by the doctor as it known to be highly effective in treating coughs, as excessive coughing affects the embryo's overall health.

"To my surprise I did not find the syrup at any of the medical shops, except for the one near the doctor's clinic who overcharged me for it. When I asked him the reason for overcharging the MRP, he told me that its not available easily due to several restrictions and therefore comes at a premium," the executive said.

As per an estimate from the pharma industry insiders, around 800-1,000 tonne of NDPS are manufactured in India every year. Around 90% is exported and little is left for domestic consumption. Taxes, price regulations are the other important reasons for the huge share of exports. India exports these drugs to around 60 countries including US, Europe and other countries, where the regulations and its implementation are more transparent.

According to the industry experts, the estimated market size for NDPS substances is about Rs 7,000 crore, the majority being CNS (Central Nervous Substance) products or psychotropic substances.

Experts claim that benzodiazepines, codeine-based cough syrups, buprenorphine, acetic anhydride are some of the drugs which are being misused as they are known to give a high on intake.

An official representing Bulk Drug Manufacturer Association (BDMA) said, "In many cases the pharma companies have been charged as an accused party and non-bailable warrant was issued against the chairman of the company. Now his entire personal as well as professional life comes in jeopardy."

"Investigators in many cases rope in the companies or stockist or dealer as accused so that the money extracted from them as bribe could be bigger," claimed a South Mumbai-based dealer dealing in psychotropic and controlled substances.

Party drugs in which pharma ingredients are used inclue meow meow and Ice.

As per a report by the United Nations-backed International Narcotics Control Board (INCB) released in March this year, there was a decrease in consumption in South Asia, which continued to have the lowest level of consumption in the world. This fall is probably attributable to a considerable decrease in the consumption of opioid analgesics in India as a consequence of legislative restrictions introduced in the past.

"Access to internationally controlled substances might also be unduly restricted out of fear of their diversion into illicit channels, as well as fear of prosecution or sanction. The latter might be exacerbated in the context of unclear, stigmatising legislation, insufficient legal knowledge among health professionals, or harsh penalties for unintentional violations. Among regulations that are well beyond the provisions of the drug control treaties and that might discourage the prescription, dispensing and use of narcotic drugs are the following: short prescription validities, special multiple-copy prescription forms, onerous record-keeping requirements, and overly restricted access to prescription forms, prescribing/dispensing agents and narcotic drugs (which are often especially limited in rural areas)," it said.

As per the latest national drug enforcement statistics for March, about 2,534 cases of drug seizure have been registered (till March) this year by different investigating agencies on pan-India basis. It stood at 27,238; 23,709; 23,041; 13,268 during 2015; 2014; 2013 and 2012, respectively.

Industry insiders say the recent seizure of ephedrine worth over Rs 2,000 crore from Solapur unit of Avon Pharma by Thane police has further raised their apprehensions about being targeted. Former actress Mamata Kulkarni, her husband Vickey Goswami along with eight others are accused in the case. Ephedrine, a controlled substance whose basic properties can be turned into a methamphetamine, a party drug known as Ice in the party circles.

"Opioid analgesics like morphine are indispensable for the treatment of pain caused by cancer, HIV/AIDS, cardiovascular disease, etc, are also not easily available. The government has to understand that they cannot harass the doctors, pharma companies, chemists, stockists in this way," said Dr Nagesh Simba, ex-president, Indian Association of Palliative Care (IAPC). The medicine supplier dna spoke to said that the chemists, except for those near major hospitals normally avoid keeping these medicines for fear of getting into problems with the law. The situation is grimmer in smaller cities, they said.

The NDPS Act 1985 has been enacted by the government to combat illicit trafficking of narcotic drugs, psychotropic substances, controlled chemicals. The law allows for a multi-agency enforcement system comprising a number of central government enforcement agencies besides the Central Bureau of Narcotics, such as Narcotics Control Bureau, Customs, Central Excise, Para-military Forces as well as state government agencies like State Police, FDA.

The stakeholders recently took up the matter with Ministry of Finance (Department of Revenue), apprising the authorities about the problems faced by the industry due to the regulatory problems. The associations in their presentation pointed out that there should be a single nodal agency for licensing and supervision as is done in the US by Attorney General through the office of Drug Enforcement Administration (DEA). The associations also want provisions to be made in the law of fine and other penal actions in case of minor discrepancies such as error in compliance or lesser wrongs.

However, the investigating agencies and legal experts differ.

Kumar Sanjay Jha, zonal director with the Narcotics Control Bureau (NCB), the apex co-ordinating agency, said the role of his organisation is that of keeping a tab whether the said drugs move only within the declared jurisdiction.

On the other hand, M N Singh, former police commissioner of Mumbai, rubbishes the pharma industry's claim as "crocodile tears".

"Genuine companies or dealers/stockists, pharmacists and other stakeholders from the industry do not face any problem. It's only those who indulge in hanky panky get into trouble," he said.

Talking about the legalities of the issue, RM Upadhyay, a Bandra-based lawyer and a specialist in NDPS cases, said, "There are many loopholes in the existing laws which need to be fixed. Also, the investigators should be trained and regular checks on the entire production and movement of these drugs should be done, which normally does not happen."

Dr Dinesh Verma, meantime, continues to rue the day he enrolled in DNB in psychiatry.

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