Tag: GMP

India aims to tighten quality of drugs

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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In a move to improve quality of drugs manufactured in India and mend its image as the pharmacy of the world, the Central Government has decided to implement Schedule M to tighten the manufacturing practices of pharmaceutical companies in India.

The Good Manufacturing Practice System was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Act, 1945. New GMP Standard in Schedule M was made in 2001 and implemented in 2005.

Schedule M prescribes requirements to facilities for maintenance, manufacturing, control and safety testing, storage and transport material, written procedures and records, traceability etc.

Issues according to the ministry, which inspected over 160 units and 14 public testing labs range from poor documentation, absence of testing incoming raw material, quality failure investigation, professionally qualified employees amongst others.

Companies have been given six to 12 months to adhere to requirements starting August 1. Companies with a turnover of over Rs 250 crore will be given six months and those with a turnover of below Rs 250 crore 1 year to comply to standards. The certification will be valid for 3 years.

While this step is expected to be positive especially at a time when Indian companies have been in the dock due to recent global incidents of substandard drugs, there are some concerns point out experts.

For example, one of big concerns is that currently the pharma companies come under the purview of state regulators. Hence the power to issue or cancel licenses is with state governments. The concern then is that the central government does not have the power to implement the compliance standards.

Also, while Schedule M became mandatory in the law in 2005 companies have struggled to implement it for the last 18 years. Many of the smaller companies for example might need to upgrade their existing facilities to comply with the standards, to do so they will require capital and infrastructure, which they might lack. An example of this is quality control labs, which were made compulsory in 2005 but companies did not comply due to inability to afford setting up the units.

Lastly, the timelines of 6 months to 1 year might not be feasible for the large number companies to adhere to the standards. India currently has around 10,500 drug manufacturers including MSMEs but only 2,000 companies mainly exporters are expected to have a good manufacturing certificate. That means 8,000 companies needing to comply to standards set out in Schedule M in just the span of a year might be a tall task.

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HMA Agro Industries IPO: GMP dips as issue opens for subscription — should you bid?

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Rs 480-crore initial share sale of HMA Agro Industries opened for public subscription on Tuesday (June 20) and will conclude on Friday (June 23). Shares of HMA Agro Industries are commanding a premium of Rs 24 in grey market today, according to market observers. This was lesser than a GMP of Rs 28 level on Monday (June 19).

However, it is important to note that grey market premiums are just an indicator as to how the company’s shares are stacked up in the unlisted market and are subject to change rapidly.

HMA Agro Industries has fixed a price band of Rs Rs 555-585 per equity share for the IPO (initial public offer). Investors can bid for a minimum of 25 equity shares and in multiples thereafter.

Should you subscribe?

Ravi Singhal, CEO of GCL Broking said that there are several legal proceedings pending against the promoters, and the books also include contingent liabilities that may escalate. As a result, Singhal believes, the IPO should be avoided from a corporate governance perspective.

The initial share sale comprises a fresh issue of equity shares up to Rs 150 crore and an offer for sale (OFS) of Rs 330 crore by promoters and selling shareholders, which means nearly 70 percent of the money from the issue is going to promoters.

Wajid Ahmed, Gulzar Ahmad, Mohammad Mehmood Qureshi, Mohammad Ashraf Qureshi, Zulfiqar Ahmad Qurashi, and Parvez Alam are the promoters who are participating in the OFS.

Nearly 50 percent of the issue is reserved for qualified institutional buyers (QIBs), 15 percent for non-institutional investors and the remaining 35 percent for retail investors.

Anchor investment, listing date

The company has mobilised Rs 144 crore from several anchor investors ahead of its IPO launch. In a regulatory filing, the firm said that it has finalised the allocation of 24.61 lakh shares to anchor investors, at a price of Rs 585 per share, the upper price band.

Investors, who participated in the anchor book, included Craft Emerging Market Fund PCC, Minerva Ventures Fund, Forbes EMF, Coeus Capital Opportunities Fund, Radiant Global Fund and Absolute Returns Scheme.

Craft Emerging Market Fund PCC is the biggest investor among them, investing Rs 70 crore in HMA Agro via Citadel Capital Fund, and Elite Capital Fund.

The share allotment will likely be finalised on June 29 and the listing of shares on the BSE and NSE will be on July 4.

At the upper end of the price band, the frozen buffalo meat exporter commands a market valuation of around Rs 2,929 crore.

The company proposes to utilise the proceeds from the fresh issue on working capital requirements and general corporate purposes.

Aryaman Financial Services Ltd is the sole lead manager to the issue, while Bigshare Services is the IPO registrar.

Financials

The company has posted a 64.3 percent increase in profit at Rs 117.6 crore for fiscal FY22, despite a weak operating margin. HMA Agro Industries’ revenue rose significantly by 80.6 percent to Rs 3,083.2 crore in the same period, partly on a low base in the previous year.

At the operating level, the EBITDA, or earnings before interest, tax, depreciation and amortisation, surged by 23.8 percent to Rs 120 crore compared to the previous year, but the margin dropped 170 basis points to 3.9 percent in FY22.

In the nine-month period ended December FY23, the company reported a profit of Rs 113.2 crore on revenue of Rs 2,370.5 crore, with EBITDA at Rs 117.9 crore and margin at 4.97 percent.

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After a lukewarm IPO, will Rustomjee realty developer’s stock stage a listing gain? Here’s what to expect

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Keystone Realtors — the property developer behind the brand Rustomjee — may make a modest debut in the secondary market on Dalal Street next week. The Mumbai-based real estate builder’s IPO worth Rs 635 crore concluded on November 16 with an overall subscription of two times the shares on offer with strong participation from high-net-worth individuals. The IPO included the fresh issuance of shares worth Rs 560 crore. 

Is there a surprise in the making on Rustomjee’s listing day?

The company has failed to command a premium in the grey market — or an unofficial market for unlisted securities, say, dealers. Generally, grey market trends are mirrored on the day of listing shares on Dalal Street bourses.

“Going by the trend in the grey market, where Keystone Realtors hardly has any activity, one can expect a muted listing,” Dinesh Gupta, Co-Founder of UnlistedZone — a firm that deals in unlisted shares, told CNBCTV18.com.

“The real estate sector was doing good and expected to do well in the next 2-3 years,” he said.

Others expect a flat-to-marginally-positive debut for Keystone on BSE and NSE.

“Keystone Realtors has a decent asset-light business model run in the MMR region. Despite a strong brand name and business model, the response to the IPO was a bit slow as, apparently, the IPO pricing was not much lucrative,” said Abhay Doshi, Co-Founder of Unlisted Arena — a portal that tracks grey markets. (Learn about what the grey market is)

The IPO of Keystone Realtors was priced at Rs 514-541 apiece under the IPO. Shares were available for bidding in multiples of 27— translating to Rs 13,878-14,607 per lot.

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Meanwhile, several experts are betting on a long-term upcycle in the country’s real estate sector.

The IPO of Rustomjee received bids for 1.7 crore shares against the 86.5 lakh shares on offer. Up to 50 percent of the issue was reserved for QIBs, 15 percent for non-institutional investors — also known as high net-worth individuals — and the remainder for retail investors.

ALSO READ: Check out all important details about Keystone Realtors IPO

Catch latest market updates with CNBCTV18.com’s blog

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Fusion Micro Finance shares to hit D-Street this week — here’s what the grey market suggests

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Fusion Micro Finance — a New Delhi-based financier — is all set to begin its journey in the secondary market on Dalal Street next week. Dealers said the company commanded a premium of Rs 5-40 in the grey market — an unofficial market for unlisted securities — since its IPO, which concluded on Friday with a total subscription of three times.

Here’s what the grey market trend suggests:

The Fusion Micro Finance IPO, to raise up to Rs 1,104 crore, concluded on Friday with bids for 6.3 crore shares against the 2.1 crore shares on offer with a strong response from qualified institutional investors. The IPO included the fresh issuance of shares worth Rs 600 crore.

Out of the total issue, a portion of 50 percent was reserved for QIBs, 15 percent for high-net-worth investors and 35 percent for retail investors.

Potential investors could bid for shares of Fusion Micro Finance — a New Delhi-based financier — in a price band of Rs 350-368 in multiples of 40 under the IPO.

Fusion Micro Finance saw a 4.7 percent increase in revenue to Rs 82.8 crore for the year ended March 2022 compared with the corresponding period a year ago, according to its red herring prospectus.

Brokerages held mixed views on the Fusion Micro Finance IPO.

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DCX Systems shines in grey market after IPO attracts strong investor interest — here’s what to expect on listing day

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Bengaluru-based DCX Systems, a Bengaluru-based manufacturer of cables and wire harness assemblies, commanded a premium in the grey market — or an unofficial market for unlisted securities — a day after the company’s IPO concluded with a strong response across different types of investors. The IPO — to raise up to Rs 500 crore — included fresh issuance of shares worth Rs 400 crore.

Dealers said the IPO commands a premium of around 70-80 in the grey market.

“DCX Systems got an outstanding response amid the string of IPOs on D-Street. The IPO was priced more reasonably compared to the couple of IPOs open for subscription,” Abhay Doshi, Co-Founder of Unlisted Arena — a portal that tracks grey markets and deals in unlisted securities — told CNBCTV18.com. (Learn about what grey market really is)

Three other companies have launched their IPOs this week: Fusion Micro Finance, Bikaji Foods International and Global Health (Medanta).

Doshi expects a premium of 25-30 percent on the listing day given the company’s valuation and investor response provided the the broader market remains stable.

The DCX Systems IPO was available for bidding within a price range of Rs 197-207 in multiples of 72 for three trading days till November 2.

At the end of the third day of the bidding process, the IPO received bids for 104.7 crore shares against the 1.5 crore shares on offer, according to exchange data.

DCX Systems shares are likely be listed on bourses BSE and NSE on November 11.

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Electronics Mart shares make a solid debut — shares list at premium over issue price

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Electronics Mart — a retailer of consumer durables and electronics — made a strong debut in the secondary market on Monday. Its stock listed at Rs 89.4 apiece on BSE — a premium of 51.5 percent over the upper end of its IPO price range. On NSE, the stock began its journey at Rs 90, a premium of 52.5 percent.

The stock closed at Rs 84.5 apiece on BSE and Rs 83.7 apiece on NSE — a premium of 42-43 percent.

The listing was in line with the trend in the grey market — an unofficial market for unlisted securities — over the past few days. Dealers said the company had commanded a grey market premium of Rs 25-35 since the launch of the IPO.

“The response of investors seems to be very selective in the primary market. The IPO was priced reasonably leaving enough on table for investors,” Abhay Doshi, Co-Founder of Unlisted Arena — a portal that tracks grey markets and deals in unlisted securities — told CNBCTV18.com.

Learn about what grey market really is

The initial share sale of Electronics Mart, to raise up to Rs 500 crore, saw a strong response from investors, especially qualified institutional buyers and high net worth individuals. The IPO concluded on October 7 with an overall subscription of 71.9 times the equity on offer.

Up to 50 percent of the public offer was reserved for QIBs, 15 percent for non-institutional investors (NIIs) and 35 percent for retail investors.

Potential investors could bid for Electronics Mart shares in a price range of Rs 56-59 apiece in multiples of 254 under the IPO.

A number of analysts held positive views on the Electronics Mart issue.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Tracxn Tech IPO to hit Dalal Street today — here’s what grey market indicates

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Tracxn Technologies is all set to launch an IPO on Monday, October 10 to raise up to Rs 309 crore. The initial share sale of Tracxn Tech — a Bengaluru-based provider of market intelligence data — is entirely an offer for sale (OFS), which means the company will not get any proceeds. 

Dealers said Tracxn Technologies commanded a premium of around Rs 10 in the grey market ahead of the IPO. 

“Tracxn has emerged as a major player among private market data services providers offering enterprise grade data curation. The company’s operations being based in India provide an advantage in cost effectiveness as compared to its global competitors,” Abhay Doshi, Co-Founder of Unlisted Arena — a portal that tracks grey markets and deals in unlisted securities — told CNBCTV18.com.

“The company was making losses till the year ended March 2022 and has posted positive results for the first three months of the current financial year. Hence, it will be too early to comment on its performance and valuation,” he said.

Some find the valuation of the Traxcn issue to be expensive.

“There is no attraction in Traxcn Technologies in the grey market… We feel the issue is over priced,” said Dinesh Gupta, Co-Founder of UnlistedZone, another firm that deals in unlisted shares.

Potential investors will be able to bid for Tracxn Tech shares in a price band of Rs 75-80 in multiples of 185, translating to Rs  13,875-14,800 per lot.

The IPO will remain open for three trading days till October 12. The basis of allotment is likely to be finalised on October 17 and the credit of shares to demat accounts on October 19.

Tracxn Tech shares are likely to be listed on bourses BSE and NSE on October 20.

Grey market is an unofficial market for unlisted securities.

Learn about what grey market really is

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Grey market points to a strong debut for Harsha Engineers shares on Dalal Street

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Harsha Engineers International — an Ahmedabad-based precision bearing cage manufacturer — is all set to make a debut on exchanges BSE and NSE on Monday. According to dealers, Harsha Engineers commanded a premium of Rs 170-240 in the grey market —  or an unofficial market for unlisted securities —  since the launch of its IPO, which saw a robust response from investors across categories.

Harsha Engineers International’s IPO, to raise up to Rs 755 crore, was open for subscription from September 14 to 16 wherein potential investors could bid for the company’s shares in a price band of Rs 314-330 apiece in multiples of 45. The IPO was a combination of fresh issuance of shares worth up to Rs 455 and an offer for sale (OFS) by existing shareholders.

“Harsha Engineers got a voluminous subscription due to its decent prospects and pricing. However, a global sell-off may become a culprit and dent the listing prospects to some extent,” Abhay Doshi, Co-Founder of Unlisted Arena — a portal that tracks grey markets and deals in unlisted securities — told CNBCTV18.com.

“Nonetheless, Harsha Engineers is expected to make a strong debut and list in the Rs 450-500 range, rewarding applicants generously,” Doshi said.

Learn about what grey market really is

Harsha Engineers’ was the fourth initial share sale to hit Dalal Street within a little over a month, following the primary market offerings of Syrma SGS, DreamFolks and Tamilnad Mercantile Bank.

Many brokerages had recommended subscribing to the Harsha Engineers IPO.

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Explained: What is GMP and why has its absence in the new Drugs, Medical Devices and Cosmetic bill sparked a debate?

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Union Health Ministry recently published a new draft bill to replace the antiquated Drugs and Cosmetics Act of 1940. This draft has sparked a debate as critics say that the government has not just failed to address the issues related to the good manufacturing practices (GMP) in the pharma industry but also not mentioned anything about it in the bill.

So, first up, what are GMPs in the pharmaceutical industry?

The World Health Organization (WHO) defines GMPs as a compliance mechanism for ensuring that products are consistently produced and controlled according to quality standards. It is designed to mitigate the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

It also enumerates risks such as unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

What do the GMPs lack?

In 1988, India incorporated the system of GMPs via the rules framed by the government, instead of the Parliament. The GMPs were not made the centrepiece of the government’s regulatory mechanism. When compared to the United States, the focus is on the GMPs to ensure the manufacturing units produce drugs according to the quality standards.

According to American law, any drug produced in a manufacturing facility, that fails to comply with the GMPs is considered ‘adulterated’. It has also made the publication of reports of investigation compulsory for the instigating officer. On the other hand, Indian law did not contain any such criminal penalties.

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“At the most, licences may be cancelled, but since the inspection reports are never published, citizens have no idea if the drug inspectors are conducting GMP compliance-related inspections”, said Dinesh Thakur, the whistleblower in the Ranbaxy case, and Prashant Reddy T, a lawyer, in their article titled ‘A new legislation that mirrors the old’.

They also added that there is ample evidence to suggest that the investigations were not carried out and the newly drafted bill does nothing to change this system.

Why are GMPs important?

One of the biggest problems that have plagued the Indian pharmaceutical industry is the increase in the number of drugs found that is not of standard quality (NSQ).

On February 3, 2017, while answering a question in the Lok Sabha, the Minister of State of the Health and Family Welfare Ministry spoke about the number of NSQ drugs found in an extensive nationwide survey conducted from 2014 to 2016, which assessed the extent of NSQ/spurious drugs in the market by testing 47,954 randomly drawn samples. The result showed that 0.0245 percent were spurious and nearly 3.16 percent were NSQ.

A research paper titled ‘Drug regulation in India: The working performance of CDSCO and SRDAs’ (September 2019) by Shree Agnihotri and Sumati Chandrashekaran mentioned, “As per data from RTI responses, approximately 7 in every 100 drug samples are found NSQ in Uttarakhand and Odisha”.

A report released by the Authentication Solution Providers’ Association (ASPA) (an organisation working against fake medical products) in 2022 showed that during the COVID-19 pandemic, incidents of substandard and falsified (SF) medical products increased by almost 47 percent from 2020 to 2021. Products included vaccines, medicines, test kits, antibiotics, face masks and sanitisers.

Comparison between US and India compliance practices

In the earlier Act, the Indian GMP system did not mention several points like considering products adulterated if the GMP was not followed, separate GMP for biological products, the definition of investigational drugs, and the inclusion of experimented drugs in GMP, etc.

It also left terms such as ‘component’, ‘non-fibre’, ‘fibre’, ‘Quality Control Unit’, ‘in process material’, ‘acceptance criteria’, ‘medical feed’, ‘medical premix’, ‘representative sample’ and many others undefined.

According to FDA documents, non-compliance with GMP norms could attract stringent regulatory actions, whereas, in India, similar action would not have been classified as ‘adulterated’. In the worst-case scenario, the licence of the company could be cancelled.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

eMudhra makes decent market debut as shares list at 6% premium over issue price

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Shares of eMudhra — a digital trust services and enterprise solutions provider — debuted in the secondary market at a premium over its issue price on Wednesday. The stock  opened at Rs 271 apiece on BSE, a premium of Rs 15 or 5.9 percent over the upper end of its IPO price range.

On NSE, eMudhra shares began their journey at Rs 270, a premium of Rs 14 or 5.5 percent over the issue price of Rs 256.

The listing was in contrast to the trend seen in the grey market — an unofficial market for unlisted securities — over the past few days.

Dealers said eMudhra shares changed hands at a discount of Rs 5 to the issue price on Wednesday ahead of the listing on BSE and NSE.

ALSO READ: What grey market really is

“eMudhra received a soft response from investors owing to its rich pricing and jittery primary market sentiments. The company has a significant market share but intensifying competition cannot be ruled out,” Abhay Doshi, Co-Founder of Unlisted Arena — a portal that tracks grey markets and deals in unlisted securities — told CNBCTV18.com. 

He had expected the stock to list around Rs 250-260 apiece.

The company’s IPO to raise up to Rs 413 crore through a combination of fresh issuance and an offer for sale (OFS) was open from May 20 to May 24, and saw an overall subscription of 104 percent the shares on offer.

Potential investors could bid for eMudhra shares in a price band of Rs 243-256 in multiples of 58 under the IPO. At the upper end of the price band, one lot is worth Rs 14,848.

The listing of eMudhra shares comes amid wild swings on Dalal Street, with the Nifty50 benchmark having retreated almost 11 percent from its peaks in October last year. Sustained foreign fund outflows and concerns about receding global growth have dampened the overall sentiment in the market.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow